Loading clinical trials...

12- Week Open Label Treatment of Refractory Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE4

12- Week Open Label Treatment of Refractory Bipolar Depression

12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

NCT00223496•The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Detailed Description

)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 2\) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•diagnosis of bipolar disorder I or II according to M.I.N.I.
•patient has signed informed consent
•male, or female who is using effective birth control if of child bearing age
•age 18 and above
•currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
•score of more than 19 on the MADRS
•history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant

Exclusion Criteria

•current liver disease,
•illness precluding the use of depakote er
•patients who have been treated with a DEP and AZP combination in the past
•Alcohol/drug dependence in the past one month
•CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
•history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
•thyroid dysfunction
•unstable general medical condition
•require antipsychotic other than abilify

Locations (1)

Univ of Texas Helath Science Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

May 16, 2017

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Aripiprazole

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

12- Week Open Label Treatment of Refractory Bipolar Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder