Clinical trials: Bipolar I Depression
Bipolar Disorder, Depression
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder.
- Trial name
- NCT02670551
- Testing
- Cariprazine
- Where
- 74 sites in United States, Bulgaria and 4 more
- Volunteers
- 488 people
- Sponsor
- Forest Laboratories
Bipolar I Disorder
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients.
- Trial name
- NCT00958633
- Testing
- Escitalopram, Bupropion XL
- Where
- Canada
- Volunteers
- 237 people
- Sponsor
- University of British Columbia
Bipolar Disorder
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet…
- Trial name
- NCT00194116
- Testing
- Divalproex Sodium ER
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Major Depressive Disorder, Bipolar I and Bipolar II
Microbiome of Depression & Treatment Response to Citalopram
The purpose of this study is to evaluate the feasibility of developing a microbiome probe of depression and to evaluate the microbiome change in a preliminary analysis of treatment response (n=20) vs.
- Trial name
- NCT02330068
- Testing
- citalopram
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Bipolar I Disorder
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived…
- Trial name
- NCT05977023
- Testing
- NMDAE
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- China Medical University Hospital
Bipolar Disorder
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451
This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451.
- Trial name
- AZD4451 SAD (NCT01196676)
- Testing
- AZD4451
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bipolar Disorder
Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.
The objective of this pilot study is to test the feasibility of a larger planned trial. The objective of this larger trial will be to determine the extent to which aspects of circadian rhythmicity, including, sleep/wake rhythms…
- Trial name
- Rhythms (NCT00726154)
- Testing
- IPSRT, Collaborative Care
- Where
- United States
- Sponsor
- University of Pittsburgh
Bipolar Disorder
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who…
- Trial name
- NCT00490971
- Testing
- Olanzapine, Paliperidone ER
- Where
- 78 sites in United States, Bulgaria and 14 more
- Volunteers
- 768 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Severe Bipolar I Disorder (Diagnosis), Bipolar I Disorder, Most Recent Episode Mixed, in Remission
FIbrosis and Steatosis in Patients With Psychiatric Illness
Background: Severe psychiatric diseases (schizophrenia, bipolarity, depression, anxious syndrome) are often associated with a metabolic syndrome, including Non-Alcoholic Steato Hepatitis, probably misdiagnosed in patients with…
- Conditions
- Severe Bipolar I Disorder (Diagnosis), Bipolar I Disorder, Most Recent Episode Mixed, in Remission, Depression Psychotic Feature, Mood-Incongruent Delusion
- Trial name
- FibroPsy (NCT05965232)
- Testing
- Fibroscan
- Where
- France
- Volunteers
- 385 people
- Sponsor
- Centre Hospitalier Esquirol
Bipolar Disorders, Mood Disorders
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
- Conditions
- Bipolar Disorders, Mood Disorders, Affective Disorders, Psychotic
- Trial name
- NCT00240721
- Testing
- topiramate
- Volunteers
- 363 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Major Depressive Episode, Bipolar Depression
NeoSync TMS Treatment for Bipolar I Depression
This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a…
- Conditions
- Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
- Trial name
- NESTTBID (NCT02839798)
- Testing
- NEST (NeoSync EEG Synchronized TMS)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Butler Hospital
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01305408
- Testing
- Armodafinil
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 399 people
- Sponsor
- Cephalon
Bipolar I Disorder, Depression, Anxiety
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress…
- Conditions
- Bipolar I Disorder, Depression, Anxiety, Stress
- Trial name
- NCT05837104
- Testing
- Magnesium vitamin B6
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Mclean Hospital
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder
The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy.
- Trial name
- MBCT (NCT01126827)
- Testing
- Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Massachusetts General Hospital
Treatment Resistant Depression
Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine
The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine.
- Trial name
- NCT03290963
- Testing
- Lithium, Ketamine
- Where
- United States
- Sponsor
- William V. Bobo, M.D.
Bipolar Depression
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
- Trial name
- NCT00868959
- Testing
- lurasidone
- Where
- 151 sites in United States, Canada and 13 more
- Volunteers
- 817 people
- Sponsor
- Sumitomo Pharma America, Inc.
Major Depression, Bipolar I Disorder
The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
The purpose of this research study is to find out if the medication known as ketamine can help the symptoms of depression. This drug is approved by the Food and Drug Administration (FDA) but the investigators will use it for a…
- Conditions
- Major Depression, Bipolar I Disorder, Bipolar II Disorder, Unipolar Depression
- Trial name
- Bio-K (NCT03156504)
- Testing
- Ketamine Hydrochloride
- Where
- 4 sites in United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
Multimorbidity, Older Adults (65 Years and Older)
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
The goal of this clinical trial is to learn if I-CONNECT (Integrated Care for Older Adults with Major Depression and Physical Multimorbidity) can improve the health and well-being of older adults with depression or bipolar…
- Conditions
- Multimorbidity, Older Adults (65 Years and Older), Mood Disorders, Depression - Major Depressive Disorder
- Trial name
- I-CONNECT (NCT07211750)
- Testing
- integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
- Where
- Belgium
- Volunteers
- 82 people
- Sponsor
- KU Leuven
Bipolar Depression
12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression
Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar Disorders (BD). Increased levels of circulating proteins known as cytokines that promote inflammation have been consistently reported in…
- Trial name
- NCT02363738
- Testing
- Infliximab, Saline
- Where
- 2 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- University Health Network, Toronto