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Depakote-ER for Depressive and Bipolar Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by Cambridge Health Alliance.
Recruitment status was:  Active, not recruiting
Northwestern University
Information provided by:
Cambridge Health Alliance Identifier:
First received: September 12, 2005
Last updated: April 13, 2006
Last verified: April 2006
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-Blind
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
Estimated Study Completion Date: September 2005
Detailed Description:
Study is 6 weeks long, with 7 clinical visits.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00226343

United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
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 Identifier (NCT Number): Identifier: NCT00226343     History of Changes
Other Study ID Numbers:
Study First Received: September 12, 2005
Last Updated: April 13, 2006

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 processed this record on February 20, 2017