Clinical trials: bipolar
Bipolar Disorder
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
- Trial name
- NCT01124877
- Testing
- ziprasidone oral capsules
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Depression
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications.
- Trial name
- NCT01566591
- Testing
- Deep TMS Treatment
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 120 people
- Sponsor
- Brainsway
Schizophrenia
Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as…
- Trial name
- NCT00825539
- Testing
- AQW051
- Where
- 7 sites in United States
- Volunteers
- 68 people
- Sponsor
- Novartis Pharmaceuticals
Agitation
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with…
- Trial name
- NCT02525991
- Testing
- Staccato® Delivery System Loxapine (ADASUVE®)
- Where
- Spain
- Volunteers
- 323 people
- Sponsor
- Ferrer Internacional S.A.
Schizophrenia, Bipolar I Disorder
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar…
- Trial name
- NCT03854409
- Testing
- Aripiprazole
- Where
- 4 sites in United States
- Volunteers
- 72 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Schizophrenia
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
This is a two-part trial. The primary objective of Part A is to estimate the ratio of geometric means of pharmacokinetic (PK) parameters and their within-subject variability for the 300mg quetiapine tablet formulation A and the…
- Trial name
- NCT03872596
- Testing
- Seroquel IR 300mg, Seroquel IR 25mg, Quetiapine Formulation A 300mg
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder, Acute Mania
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder.
- Trial name
- NCT03287869
- Testing
- Brexpiprazole
- Where
- 73 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 I Disorder, Schizophrenia
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.
- Trial name
- NCT04127058
- Testing
- Iloperidone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vanda Pharmaceuticals
Bipolar I Disorder, Manic Episode
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
- Trial name
- NCT03257865
- Testing
- Brexpiprazole
- Where
- 38 sites in United States, Croatia and 1 more
- Volunteers
- 333 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder, Manic Episode
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
- Trial name
- NCT03259555
- Testing
- Brexpiprazole
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 322 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Predictors of Recurrence in Bipolar Disorder in Spain
Observational, prospective (1 year follow up), multicenter, non-interventional open label study in order to assess the factors that predict onset of mood disorders episodes (depression, mania, hypomania and mixed) in stabilized…
- Trial name
- PREBIS (NCT00690859)
- Where
- 49 sites in Spain
- Volunteers
- 595 people
- Sponsor
- AstraZeneca
Bipolar Disorder
SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)
The aim of the study is to assess the tolerability, efficacy and safety of a new lithium sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder poor tolerant to lithium immediate-release…
- Trial name
- NCT03210480
- Testing
- Lithium sulphate prolonged-release 660 mg, Lithium carbonate immediate-release 150 mg and 300 mg
- Where
- 6 sites in Italy
- Volunteers
- 85 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Schizophrenia, Autism
Pediatric Open-Label Extension Study
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have…
- Conditions
- Schizophrenia, Autism, Bipolar Depression
- Trial name
- NCT01914393
- Testing
- Lurasidone 20, 40, 60, 80 mg, flexibly dosed
- Where
- 88 sites in United States, Bulgaria and 13 more
- Volunteers
- 702 people
- Sponsor
- Sumitomo Pharma America, Inc.
Schizophrenia, Bipolar 1 Disorder
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls.
- Conditions
- Schizophrenia, Bipolar 1 Disorder, Major Depressive Disorder
- Trial name
- NCT03643159
- Testing
- Abilify MyCite - Digital Medicine System, Aripiprazole or other oral antipsychotics
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Psychomotor Agitation, Schizophrenia
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
- Conditions
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
- Trial name
- NCT04148963
- Testing
- Inhaled loxapine
- Volunteers
- 150 people
- Sponsor
- Lee's Pharmaceutical Limited
Bipolar 1 Disorder
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
- Trial name
- NCT01674010
- Testing
- ELND005, Lamotrigine, Valproic acid
- Where
- 82 sites in United States, Bulgaria and 7 more
- Volunteers
- 309 people
- Sponsor
- OPKO Health, Inc.
Major Depressive Disorder, Bipolar Disorder
Testing the Value of Smartphone Assessments of People With Mood Disorders
The purpose of this study is two-fold: 1. To identify the best smartphone data features (based on keyboard, sensor, voice/speech data) that correlate with mood, anxiety, and cognitive assessments in patients with Major Depressive…
- Trial name
- NCT03429361
- Testing
- Health by Mindstrong
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Mindstrong
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, Depression
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I…
- Trial name
- NCT02670538
- Testing
- Cariprazine
- Where
- 89 sites in United States, Bulgaria and 6 more
- Volunteers
- 493 people
- Sponsor
- Forest Laboratories