Clinical trials: Bipolar II Depression
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Depression
The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive
To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric performance and residual depressive symptoms in patients who have been diagnosed with unipolar and bipolar depression but currently DO NOT…
- Trial name
- JNJ-DEP (NCT02677207)
- Testing
- JNJ-39393406
- Where
- 4 sites in Moldova, Romania
- Volunteers
- 80 people
- Sponsor
- Tangent Data
Depressive Disorder, Depressive Disorder, Major
Synaptic Imaging and Network Activity in Treatment Resistant Depression
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD).
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder
- Trial name
- SIGNATURE (NCT05870501)
- Testing
- Ketamine, Midazolam
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- King's College London
Bipolar II Disorder, Major Depressive Episode
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.
- Trial name
- NCT00237666
- Testing
- Ziprasidone
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medical Research Network
Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.
- Trial name
- NCT04433845
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sheppard Pratt Health System
Bipolar Disorder, Bipolar Depression
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT03603561
- Testing
- cTBS
- Where
- 2 sites in Belgium
- Volunteers
- 40 people
- Sponsor
- Universiteit Antwerpen
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder
rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II
This research study evaluates an experimental device for the treatment of the depressed phase of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an experimental procedure where a device delivers…
- Trial name
- rTMS (NCT00447096)
- Testing
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Where
- United States
- Sponsor
- University of Texas Southwestern Medical Center
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 Disorder, Depression
Relapse Prevention for Bipolar Type-II Disorder
This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar…
- Trial name
- NCT00044616
- Testing
- Fluoxetine, Lithium
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- University of Pennsylvania
Bipolar Depression
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
- Trial name
- NCT00322764
- Testing
- Uridine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Repligen Corporation
Bipolar Disorder, Bipolar Depression
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a…
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- X-CEED (NCT07172516)
- Testing
- Azetukalner
- Where
- 44 sites in United States, Bulgaria and 2 more
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar Affective Disorder
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving…
- Trial name
- NCT07412132
- Testing
- Lacosamide
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- University of Sao Paulo
Bipolar Disorder
Clinical Trial of a Nutritional Supplement in Adults With Bipolar Disorder
The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when studied under randomized and fully blinded…
- Trial name
- NCT00109577
- Testing
- MCN36 (nutritional supplement)
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- University of Calgary
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Bipolar Disorder, Bipolar Depression
Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression
Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD).
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- KET-BD-Sustain (NCT05339074)
- Testing
- Ketamine Hydrochloride
- Where
- 3 sites in Canada
- Volunteers
- 41 people
- Sponsor
- Joshua Rosenblat
Major Depressive Disorder, Bipolar 1 Disorder
Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning
This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders…
- Conditions
- Major Depressive Disorder, Bipolar 1 Disorder, Bipolar II Disorder
- Trial name
- NCT05400785
- Testing
- Circadian Rhythms for Mood (CRM) application - Active
- Where
- South Korea
- Volunteers
- 93 people
- Sponsor
- Hucircadian
Bipolar Disorder I, Bipolar II Disorder
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking…
- Conditions
- Bipolar Disorder I, Bipolar II Disorder, Bipolar I Disorder, Bipolar Disorder
- Trial name
- NCT05705063
- Testing
- LCHF Ketogenic Diet
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
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 Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company