Depakote-ER for Depressive and Bipolar Depression

April 17, 2017 updated by: Cambridge Health Alliance

Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression

Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study is 6 weeks long, with 7 clinical visits.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics

Exclusion Criteria:

  • Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anxiety and Depressive Symptom severity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

January 1, 2006

Study Completion (ACTUAL)

August 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (ESTIMATE)

September 27, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-0007/07/03

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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