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Depakote-ER for Depressive and Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Cambridge Health Alliance.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00226343
First received: September 12, 2005
Last updated: April 13, 2006
Last verified: April 2006
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226343

Locations
United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
Northwestern University
Investigators
Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance
  More Information

No publications provided by Cambridge Health Alliance

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00226343     History of Changes
Other Study ID Numbers: 2
Study First Received: September 12, 2005
Last Updated: April 13, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 22, 2013