Clinical Research Directory

A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People

This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms. The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China. Participants will include people with anxiety disorders, depressive disorders, or bipolar disorder, as well as healthy volunteers for comparison. Participants will be followed for 3 years after enrollment, with assessments at baseline and at 1, 6, 12, 18, 24, 30, and 36 months. Study assessments will collect information about symptoms, treatment, daily functioning, and quality of life. Other study data will include biological samples, brain imaging, recordings of brain electrical activity, and measurements from wearable devices and tasks involving speech, facial expressions, and eye movements. Researchers will examine how these measurements relate to symptoms and changes in health over time. They will also develop and evaluate artificial intelligence models intended to help identify these disorders and predict treatment outcomes, relapse, and suicide or self-harm risk. This is an observational study. The researchers will not assign treatments or change participants' treatment as part of the study. Treatments received during routine clinical care will be recorded.

Stress Management With Real-time Bio-signal Biofeedback

The goal of this clinical trial is to learn if the real-time bio-signal monitoring device (Neuronicle FX2 device), combined with mindfulness-based cognitive therapy (MBCT), helps manage stress and improves symptoms of mood disorders, such as depression and anxiety. The main questions this study aims to answer are: * Does real-time bio-signal feedback mindfulness using the Neuronicle FX2 reduce perceived stress in participants with mood disorders? * Does it lead to improvements in depressive and anxiety symptoms? Researchers will compare participants receiving real-time biofeedback with the Neuronicle FX2 to those receiving no feedback during mindfulness sessions to see if the device enhances the effectiveness of stress management and symptom improvement. Participants will: * Undergo mindfulness-based cognitive therapy (MBCT) once a week for 8 weeks. * Half of the participants will receive real-time biofeedback using the Neuronicle FX2 device during mindfulness sessions, while the other half will not be provided biofeedback. * Visit the clinic every week for their mindfulness sessions and assessments. * Wear the Neuronicle FX2 device during mindfulness exercises, which will measure brainwave activity (EEG) and heart rate variability (HRV). * Participate in assessments before, during, and after the program (8wks, 16wks) to evaluate their stress, depression, and anxiety levels.

Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization

This study is a randomized controlled trial evaluating the impact of financial incentives on medication adherence among individuals with schizophrenia, schizoaffective disorder, or bipolar disorder and/or co-occurring substance use disorder who are recently discharged from involuntary hospitalization or are at high risk of future involuntary hospitalization. Participants will be randomized to receive financial incentives for adherence to long-acting injectable medications or to a control group.

Evaluating the PolarUs App in People With Bipolar Disorder

Our team recently pilot tested a new mobile app, PolarUs, co-designed with people who live with bipolar disorder (BD), to support BD self-management and quality of life (QoL) measurement. An initial study suggested the app improved QoL and mood scores over time among participants in Canada and the United States. This project aims to fully assess whether PolarUs improves QoL and mood outcomes in diverse people with BD living in Canada and the United States. To achieve this, we have (1) culturally and linguistically adapted the English version of PolarUs into French, Mandarin, and Spanish, and (2) are now conducting a randomized controlled trial (RCT) to assess whether PolarUs (in all 4 languages) improves QoL and mood outcomes in adults living with BD in Canada and the United States. Participants will: 1. Attend an eligibility assessment interview to confirm their eligibility to participate. 2. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: Group 1 - Receive access to the PolarUs app through participants' Android (Google) or iOS (Apple) mobile device for a period of 12 weeks. Group 2 - Receive access to the PolarUs app after a 12-week waiting period. During the waiting period, participants will only receive study assessments. 3. Participants will complete study assessments at the beginning and end of the 12-week period and, where appropriate, monthly during the study period. We aim to recruit approximately 480 participants from Canada and the United States to take part in the study. We would also like to understand how people with bipolar disorder use and engage with the app.

Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression

Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes. * Population: 126 patients with bipolar depression * Intervention: Pramipexole added to ongoing treatment with mood stabilizer, flexible dosing - target dose 2.1 mg/day * Control: Add-on identical placebo * Outcomes: Primary outcome is change in anhedonia symptoms between baseline and 6 weeks of intervention. Key secondary outcomes include (for example) general depression symptoms and safety measures. There will be a 15 weeks open label follow up. If shown to be effective and safe, this intervention could become a key treatment option for bipolar depression, reducing suffering and potentially lowering suicide risk.

French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls

The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60. The main questions it aims to answer are: * Can subgroups of patients sharing a common profile of social withdrawal and anhedonia be identified, with similar clinical, genetic, biological and brain imaging characteristics? * Do other dimensions (cognitive flexibility, neurodevelopmental, sensory and sleep disturbances, impulsivity) and specific clinical forms (e.g., autoimmune psychosis, metabolic abnormalities) define relevant subgroups, and how do these subgroups evolve over time? Researchers will compare patients with healthy volunteers to identify clinical and biological signatures specific to each subgroup. Participants will: * Attend an inclusion visit, two one-day assessment visits one year apart (clinical interviews, questionnaires, cognitive tests, fasting blood sample) and two brain MRI sessions * Optionally provide a stool sample collected at home * Complete questionnaires on a smartphone app and wear a connected watch (activity, sleep, heart rate) between visits * Take part in the study for about 18 months French Minds is conducted in about 35 centres in France and aims to include 2,500 patients and 500 healthy volunteers.

BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder

Bipolar disorder (BD) is often diagnosed 5 to 10 years after first symptoms, worsening prognosis. "Bipolar At-Risk" (BAR) criteria have been developed to identify people who may be in an early, prodromal stage of BD, but their long-term clinical course is not well characterized. BAROMETRE is a prospective, multicenter, naturalistic study following two groups of hospitalized psychiatric patients aged 18-65 for 36 months: patients meeting BAR criteria (without prior manic/hypomanic episode) and patients with an already diagnosed bipolar disorder (type 1 or 2), used as a clinical reference group. No experimental treatment is imposed; patients receive usual care. At inclusion, 1, 12, 24 and 36 months, participants undergo structured psychiatric interviews and clinician-rated scales (YMRS, MADRS, CGI, C-SSRS, Sachs Bipolarity Index); at 6, 18 and 30 months they complete self-report questionnaires by phone or online (BDI, HCL-32, PSQI, WHOQOL). The main hypothesis is that a clinically significant proportion (around 20%) of BAR patients will convert to a full bipolar disorder (first DSM-5 manic/hypomanic episode) within 36 months. Secondary aims are to describe and compare mood, functioning, quality of life, suicidality, sleep, substance use, trauma/PTSD symptoms, and care pathways (hospitalizations, treatment changes) between the two groups, and, exploratorily, between BAR patients who convert and those who do not. This pilot study aims to better characterize the evolution of at-risk states and generate hypotheses for larger confirmatory studies.

Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations

The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders. The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks. Secondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate. Thirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment. Finally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and/or memory-related activity shown with structural and functional MRI.

Time Restricted Eating (TRE) in Bipolar Disorder

This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder

People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations. This open-label pilot trial will assess the feasibility, acceptability, and preliminary effectiveness of a structured care pathway to support the transition from hospital to community care. The intervention includes group-based psychoeducation, individual peer support, and personalized support for community healthcare providers to improve illness insight, treatment adherence, and symptom management.

Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder

Study Objective: To evaluate the treatment effectiveness and safety by analyzing prescription patterns in a routine clinical practice setting and observing changes in clinical indicators (weight, BMI, HAM-D, CGI-S, CGI-I) among patients prescribed Lurasidone for the treatment of bipolar disorder. Study Design: Retrospective, Multi-center, Investigator-Initiated Observational Study.

Neuromodulation of Mood Switch Circuitry in Bipolar Disorder

This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD. Investigators in this study will use a technique called repetitive transcranial magnetic stimulation, or rTMS. It uses non-invasive magnetic pulses delivered to the scalp to stimulate specific areas of the brain. rTMS is already used to treat depression, and investigators are now studying whether it can be made even more effective for people with bipolar disorder by precisely targeting an individualized brain region for each participant. Participants in this study will receive two courses of rTMS, one active and one placebo (called "sham"), in a randomized order so investigators can directly compare the effects. Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity. This lets investigators identify the exact stimulation target most likely to influence the brain circuits involved in BD mood shifts. Investigators will track mood symptoms closely throughout the study to measure what changes. Investigators believe that depression in BD is partly driven by disrupted communication between two brain regions involved in processing what feels important or rewarding. Investigators want to find out whether rTMS can restore that communication and whether doing so leads to measurable improvements in depression.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment

The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments. Involving complex processes within the brain and peripheral immune system, inflammation may lead to imbalance of neurotransmitter systems and synaptic plasticity and directly contribute to the psychiatric symptoms observed in conditions such as depression, bipolar disorder (BD) and schizophrenia (SCZ). Studies show that treatment-resistant depression (TRD) is associated with elevated levels of inflammatory markers in the blood, which are linked to a lower response to conventional antidepressants. Interventions that modulate this inflammatory response, such as immunomodulatory treatments or therapies targeting pro-inflammatory cytokines, have demonstrated beneficial effects by reducing symptoms and improving patients' quality of life. A thorough understanding of the links between inflammation and treatment resistance therefore paves the way for innovative therapeutic strategies. These approaches could transform current practices by offering more personalized and effective solutions for patients suffering from chronic and resistant psychiatric disorders.

The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder

PEDAL is a group-based intervention for patients with bipolar disorder that builds on the traditional group psychoeducational program (GPP) by adding digital tools and specific strategies to help manage rapid fluctuations between affective states, known as affective lability. The program's goal is to help patients learn and develop new ways to better manage their condition, with particular attention to affective lability and other difficulties with affect regulation- challenges which are not typically addressed in current treatments. The PEDAL trial will run at five clinical sites around Oslo and Vestre Viken, aiming to recruit 120 participants with bipolar disorder. The program combines existing group sessions from GPP with new components: additional group sessions focusing on strategies for improving affect regulation such as mindfulness and distress tolerance, an online platform with all course materials including instructional videos and other resources, and an app-based mood diary. This framework maintains the benefits of regular group meetings while adding digital support tools to make the intervention more personalized and accessible. The main aim of PEDAL is to see if the new program reduces affective lability more effectively than GPP (treatment-as-usual; TAU), and both intervention groups will be compared on the level of affective lability before and after the intervention. Several secondary outcomes like mood symptoms, suicidal thoughts, perceived stress, and quality of life will also be assessed. In terms of study design, all study sites will run the PEDAL and TAU groups in parallel, and participants will be randomly assigned to either PEDAL or TAU. To qualify for the study, participants must be aged 18-65, diagnosed with bipolar disorder, able to participate in a group intervention, capable of providing informed consent, and have a smartphone or computer. People who have previously completed group psychoeducation, who are unable to complete the study period due to pregnancy or other factors, or those who cannot use the required technology are excluded. In summary, PEDAL is a novel study that modernizes the existing group psychoeducational program for bipolar disorder by targeting affective lability through skills training and digital tools, while also evaluating its reception and effects in a controlled clinical trial.

Identifying Biomarkers of Response to Digital Interventions for Mood Disorders

The proposed study will be a single-arm pragmatic clinical trial examining the feasibility of online CBT within the CAN-BIND sites and the biomarkers of treatment response to online CBT for mood disorders.

Project MOVE Bipolar

The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity: 1. brief advice (BA) to exercise (control condition); 2. BA + supervised \& home-based exercise (SHE) + health education (HE) contact control; and 3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX). The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness. The investigators will also compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels. The investigators will also compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase.

Pain, Sleep Quality, Eating Habits and Physical Activity Level in Patients With Bipolar Disorder

Bipolar disorder (BD) is a complex condition characterized by recurrence of mania, hypomania, and depression. It is characterized by changes in daily life activities, sleep status, focus problems, and cognitive fluctuations. The mortality rate due to suicide and cardiovascular diseases increases in individuals with BD. The DSM-5TR defines BD as Bipolar I Disorder (BD-1) with one or more manic episodes, Bipolar II Disorder (BD-II) with at least one severe depressive episode accompanied by at least one hypomanic episode, Cyclothymia disorder, substance-induced bipolar disorder, bipolar or related disorder related to another medical condition, other defined bipolar and related disorder, and undefined bipolar and related disorder. The lifetime prevalence of BD varies between 0.6% and 1.0% for Type I and 0.4% and 1.1% for Type II. Symptoms usually start between 14-21 years of age. Depressive episodes and lifelong single marital status are more common in females, while substance abuse is more common in males. Depression attacks are longer than manias, but the duration of attacks does not differ between types. The mean duration of depressive and manic periods is 5.2 months and 3.5 months, respectively. Pain is observed in 28.9% of patients with a diagnosis of GI, which decreases the quality of life and is a significant concern in psychological disorders.

Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models

This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues. The research will use human induced pluripotent stem cell (iPSC)-derived neural cells generated from blood samples collected from people with bipolar disorder and healthy volunteers, as well as a mouse model of mania. No participants will receive the investigational treatment. Human participants will provide blood samples only for the generation of laboratory cell models. The study will compare the effects of nanoparticle-delivered lithium with conventional lithium salts on cellular lithium uptake, disease-related molecular and functional changes, and biomarkers associated with bipolar disorder. The hypothesis is that lithium delivered by gold nanoparticles will achieve greater therapeutic effects at lower systemic lithium exposure than conventional lithium formulations, providing proof of concept for a safer and more targeted lithium delivery strategy for future clinical development.

The Effect of Cognitive Behavioral Psychoeducation on Internalized Stigma in Individuals With Bipolar Disorder

Since ancient times, societies have exhibited negative, discriminatory, labeling, and stigmatizing attitudes toward mental disorders and individuals with psychiatric conditions. This situation has negatively affected individuals with mental disorders in many aspects. Over time, individuals with mental illness adopt the stigma they experience and subsequently begin to suffer from internalized stigma. Internalized stigma, or "self-stigmatization," is the adoption of society's negative perceptions-such as being dangerous or inadequate-by the individual with the mental illness themselves. The individual gradually internalizes the prejudices, discrimination, and exclusion present in society. For instance, the societal prejudice that "one cannot be friends with individuals with bipolar disorder" manifests in the patient as "this is true, I cannot be friends with anyone." Consequently, individuals diagnosed with bipolar disorder experience internalized stigma.Psychiatric patients must contend not only with the challenges brought by their illness but also with internalized stigma. Internalized stigma in individuals with mental disorders has detrimental effects on recovery. While experiencing feelings of guilt and shame, psychiatric patients suffering from internalized stigma particularly tend to hide their illness, avoid seeking help for treatment, and face adverse processes regarding treatment compliance. Furthermore, due to the impact of stigmatization, they withdraw from society, experiencing a reduction in social interaction and loneliness. It is well-documented that individuals diagnosed with bipolar disorder experience non-compliance with treatment due to the recurrent and chronic nature of the illness. This situation increases the risk of internalized stigma in patients. Studies demonstrate that patients diagnosed with bipolar disorder experience internalized stigma. Moreover, it stands out as one of the psychiatric illness groups that experiences the highest levels of stigmatization.The management of mental illnesses is a multidimensional framework that requires not only clinical interventions but also the active participation of the patient and social support systems. In this context, psychoeducation is defined as a systematic and evidence-based psychotherapeutic intervention method aimed at informing patients and their families about the disease process, strengthening coping mechanisms, and improving quality of life. Moving beyond traditional approaches, psychoeducation aims to transform the individual and their environment from passive recipients into competent stakeholders in illness management. The fundamental building blocks of psychoeducation comprise medical information regarding the illness, problem-solving strategies, effective communication skills, and the restoration of self-confidence. While these components enable individuals to gain insight into their illness, critical objectives such as managing potential crisis moments and minimizing suicide risk come to the forefront. The literature emphasizes that psychoeducation is one of the most effective supportive methods in preventing relapses and increasing adherence to treatment. Consequently, psychoeducation is a holistic approach aimed at empowering patients and their families by focusing on developing their skills to cope with psychosocial difficulties.Studies have shown that psychoeducation is effective in reducing internalized stigma in patients with bipolar disorder. A quasi-experimental study suggested that psychoeducation reduces internalized stigma and can be implemented in hospitals. A systematic review of individuals with bipolar disorder found that psychoeducation, as a complementary strategy to pharmacotherapy, reduced the frequency of new mood episodes, the duration of hospitalization, and non-compliance with medication. The unique value of this study within the Turkish sample lies in the scarcity of randomized controlled trials (RCTs) examining the specific effect of structured psychoeducation on internalized stigma in patients with bipolar disorder, alongside the inclusion of a three-month post-intervention follow-up test. The purpose of this study is to examine the effect of psychoeducation on the level of internalized stigma in individuals diagnosed with bipolar disorder.

Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)

The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is: Does IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ? Researchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity. Participants will: * Complete six infusions of either IV ketamine or IV midazolam * Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial) * Visit the hospital for scheduled in-person visits * Join a call or videocall for scheduled remote visits * Complete a variety of different mood, cognitive and behavioral assessments

LRFN5 and OLFM4 in Bipolar Disorder

This cross-sectional observational case-control study evaluated serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) in subjects with bipolar disorder (BD) during acute manic episodes and in healthy controls (HC). The study also assessed systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and examined associations between biomarkers and clinical symptom severity, including Young Mania Rating Scale (YMRS) and Beck Depression Inventory (BDI) scores. The study aimed to investigate the potential interaction between synaptic dysregulation and immunoinflammatory abnormalities in BD.

Conceptualizing Borderline Personality Disorder as a Relationship Use Disorder

This study aims to explore a novel conceptualization of Borderline Personality Disorder (BPD) as a "Relationship Use Disorder." The research proposes that BPD shares key features with behavioral addictions, specifically addiction to interpersonal relationships. The study builds upon previous findings suggesting that individuals with BPD experience intense emotional dysregulation, including negative self-perception, shame, and a compulsive need for external validation. This addiction to relationships, much like substance use disorders, is thought to contribute significantly to the difficulties faced by these individuals, including interpersonal conflicts, self-destructive behaviors, and emotional instability. The study seeks to demonstrate that the relational difficulties central to BPD meet the diagnostic criteria for addiction as defined by the DSM-5. It will also explore how these relational struggles are mediated by dysfunctional self-perception and whether they are linked to behaviors such as compulsive sexual behaviors (CSBD) or suicidal tendencies. Additionally, the research will investigate the relationship between addiction to relationships and neurobiological factors, including endorphin levels, in individuals with BPD compared to those with bipolar disorder and healthy controls. The hypothesis is that individuals with BPD will exhibit higher levels of relationship addiction, with this addiction being tied to their perception of self-worth and emotional experiences in relationships. This innovative approach aims to refine the understanding of BPD, reduce stigma, and improve treatment strategies by providing scientific evidence supporting the conceptualization of BPD as a "Relationship Use Disorder."

Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality-based cognitive remediation (VRCR) intervention in improving cognitive performance and psychosocial functioning in individuals with schizophrenia spectrum disorders (SSD) and bipolar disorder (BD). A total of 80 participants (40 with SSD and 40 with BD) will be randomly assigned in a 1:1 ratio to receive either VRCR or treatment as usual (TAU). The VRCR intervention will be delivered using the CEREBRUM platform and will consist of 45-minute sessions administered twice weekly for 12 weeks under the supervision of trained therapists. The primary outcomes are changes in cognitive performance and psychosocial functioning, assessed using the MATRICS Consensus Cognitive Battery (MCCB) and the Personal and Social Performance (PSP) scale, respectively. Secondary outcomes include clinical symptom severity, assessed with validated rating scales, and neurobiological correlates, including functional magnetic resonance imaging (fMRI) and genetic biomarkers. Assessments will be conducted at baseline, at 3 months (post-intervention), and at 6 months (follow-up). fMRI assessments will be conducted at baseline in patients with schizophrenia spectrum disorders, whereas peripheral blood samples for genetic marker analyses will be collected at baseline and at the 3-month follow-up in patients with SSD and BD. This study is expected to provide evidence on the feasibility, acceptability, and effectiveness of VR-based cognitive remediation in SSD and BD, as well as insights into the neurobiological mechanisms underlying cognitive and functional improvements.