Clinical trials: Bipolar 1 Disorder
Mental Disorder, Schizophrenia
A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
- Conditions
- Mental Disorder, Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT06372210
- Testing
- Abilify MyCite®, D-Tect Patch
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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
Bipolar I Disorder
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
- Trial name
- NCT06273774
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar Disorder Mania
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
- Trial name
- NCT00665366
- Testing
- Aripiprazole, Lithium, Valproate
- Where
- 73 sites in Austria, Czechia and 11 more
- Volunteers
- 493 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 Disorder
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I…
- Trial name
- NCT00723450
- Testing
- lamictal
- Where
- 46 sites in United States
- Volunteers
- 301 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder, Anxiety Disorders
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
The 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…
- Trial name
- NCT01892306
- Testing
- UP CBT, Treatment as usual
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Massachusetts General Hospital
Bipolar I Disorder
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
- Trial name
- NCT00402324
- Testing
- olanzapine, divalproex
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Eli Lilly and Company
Schizophrenia, Schizophreniform Disorders
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
- Conditions
- Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
- Trial name
- NCT03187769
- Testing
- ALKS 3831, Olanzapine
- Where
- 57 sites in United States, Austria and 10 more
- Volunteers
- 426 people
- Sponsor
- Alkermes, Inc.
Bipolar Depression, Bipolar I Disorder
iTBS in Bipolar I Depression
A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with…
- Trial name
- NCT05375214
- Testing
- Magnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Bipolar Disorder
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
- Trial name
- NCT01467713
- Testing
- Ramelteon SL
- Where
- 156 sites in United States, Argentina and 3 more
- Volunteers
- 642 people
- Sponsor
- Takeda
Bipolar I
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder.
- Trial name
- ATLAS (NCT01710709)
- Testing
- Aripiprazole
- Where
- 142 sites in United States, Canada and 8 more
- Volunteers
- 748 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
- Trial name
- NCT00721955
- Testing
- Inhaled loxapine 5 mg, Inhaled loxapine 10 mg
- Where
- 6 sites in United States
- Volunteers
- 314 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
Bipolar I Disorder
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
- Trial name
- NCT01986114
- Testing
- SM-13496
- Where
- 8 sites in Japan, Lithuania and 6 more
- Volunteers
- 495 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
Bipolar I Disorder
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
- Trial name
- NCT00618748
- Testing
- Olanzapine
- Where
- 10 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Eli Lilly and Company
Bipolar I Disorder
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
- Trial name
- NCT00606281
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 258 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of…
- Trial name
- PERSISTExt (NCT01575561)
- Testing
- Lurasidone
- Where
- 71 sites in United States, Argentina and 10 more
- Volunteers
- 377 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar I Disorder
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
- Trial name
- NCT01059539
- Testing
- Cariprazine
- Where
- 35 sites in United States, Hungary and 2 more
- Volunteers
- 403 people
- Sponsor
- Forest Laboratories
Bipolar Disorder, Pediatric
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized.
- Trial name
- NCT01244815
- Testing
- asenapine, Rescue medication
- Volunteers
- 404 people
- Sponsor
- Organon and Co