We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Depakote-ER for Depressive and Bipolar Depression

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 27, 2005
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Northwestern University
Information provided by (Responsible Party):
Cambridge Health Alliance
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.

Condition Intervention Phase
Bipolar Disorder Drug: Depakote-ER Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Anxiety and Depressive Symptom severity

Estimated Enrollment: 25
Study Start Date: August 2003
Study Completion Date: August 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:
Study is 6 weeks long, with 7 clinical visits.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226343

Sponsors and Collaborators
Cambridge Health Alliance
Northwestern University
Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00226343     History of Changes
Other Study ID Numbers: CHA-IRB-0007/07/03
First Submitted: September 12, 2005
First Posted: September 27, 2005
Last Update Posted: April 18, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs