A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder
Bipolar DepressionThis study is a 52 week double-blind placebo controlled study of omega-3 polyunsaturated fatty acids (PUFAs) in bipolar disorder (who have a history of 3 or more episodes) to ascertain if omega-3 PUFAs reduce the risk of further relapse for both / either depressive or (hypo)manic episodes. This is a single-centre, 52 week, double-blind, randomised comparison of omega-3 PUFA (1g EPA and 1g DHA) versus placebo as adjunctive treatment in individuals with bipolar disorder
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Bipolar DisorderBipolar I Disorder1 moreThis research study evaluates the effects of anFDA-approved medication NAC in individuals with Bipolar Disorder. Participants in the study will will be assigned to two medication conditions and will take both NAC and a matched placebo. The order in which they take each medication will be random. Study medication will be taken for 14 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.
Feasibility of a Novel Process-based Treatment for Patients With Psychosis
SchizophreniaSchizotypal Disorder20 moreThe purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting.
Client-led Online Therapy for People Diagnosed With Bipolar Disorder
Bipolar Spectrum DisorderThe study aims to investigate the use of Method of Levels therapy (MOL) delivered online via videoconferencing for people who have received a diagnosis of a bipolar spectrum disorder. People are typically offered medication and talking therapies aimed at reducing symptoms and managing relapse. Research shows, however, that people tend to report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse- free. Having choice and control over treatment have been identified as important aspects of recovery in bipolar disorder. MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals. MOL has already been applied to a range of mental health difficulties with promising results. The aims of the study are to: Investigate whether it is feasible to deliver MOL online to people with a bipolar spectrum disorder Investigate whether MOL delivered online is an acceptable psychological intervention for people with a bipolar spectrum disorder Identify the elements of therapy that people want choice over and the impact and importance of these elements Determine whether there is a link between how much control over therapy people perceive themselves to have and the degree to which they generate new perspectives, thoughts and insights into their problems. The current study will aim to recruit a minimum of 12 participants with a diagnosis of Bipolar Spectrum Disorder to account for 30% attrition (a conservative estimate based on reported attrition rates for published studies evaluating Cognitive Behavioural Therapy (CBT) for Bipolar Disorder). Therefore, the study aims to retain 8 participants for completion of the study. This is considered feasible in the available timeframe as recruitment will adopt a broad strategy. Participants will be offered MOL sessions online for up to six months. Potential participants will choose how many sessions to have, when to attend and what to talk about. Investigators will consider how many participants chose to take part and remain in the study to the end. The investigators will also ask participants about their experiences of the intervention and any changes participants may have noticed via feedback questionnaires and an interview.
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive...
Bipolar Disorder IBipolar Disorder II1 moreThis is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy...
Antipsychotic-induced Weight Gain (AIWG)This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic medications.
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Bipolar DepressionThe study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Bipolar DisorderAnxiety DisordersThe specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.
Benefits Management for People With Psychiatric Disabilities
Dual DiagnosisSchizophrenia1 moreThis stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Bipolar DepressionLurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.