Clinical trials: Bipolar II Disorder
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
Bipolar Disorder
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
- Trial name
- NCT00254774
- Testing
- quetiapine fumarate or valproate
- Where
- 3 sites in Germany
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
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
Bipolar Disorder
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with…
- Trial name
- NCT00154323
- Testing
- Oxcarbazepine
- Volunteers
- 55 people
- Sponsor
- Novartis
Metastatic Castration-resistant Prostate Cancer
The COSMYC Trial (COmbined Suppression of MYC)
This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that…
- Trial name
- NCT06922318
- Testing
- ZEN-3694, Testosterone cypionate, Enzalutamide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bipolar II Disorder
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
- Trial name
- LiLa-Bipolar (NCT06184581)
- Testing
- Lithium Carbonate, Lamotrigine
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
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 I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
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
Recurrent Prostate Cancer
Bipolar Androgen-based Therapy for Prostate Cancer (BAT)
The purpose of this study is to determine the safety and clinical effects of alternating androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer as first line hormonal therapy, to assess the…
- Trial name
- BAT (NCT01750398)
- Testing
- Testosterone cypionate, Goserelin, Leuprolide
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Prostate Cancer
RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of…
- Trial name
- Restore (NCT02090114)
- Testing
- Testosterone cypionate, Testosterone Enanthate, Abiraterone acetate
- Where
- 2 sites in United States
- Volunteers
- 112 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Disorder
Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function.
- Trial name
- MONARCAII (NCT02221336)
- Testing
- The MONARCA II system, Non-MONARCA II system
- Where
- Denmark
- Volunteers
- 146 people
- Sponsor
- Psychiatric Centre Rigshospitalet
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