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Depakote-ER for Depressive and Bipolar Depression

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.
ClinicalTrials.gov Identifier: NCT00226343
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Cambridge Health Alliance

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Drug: Depakote-ER Phase 4

Detailed Description:
Study is 6 weeks long, with 7 clinical visits.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Study Start Date : August 2003
Primary Completion Date : January 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources




Primary Outcome Measures :
  1. Anxiety and Depressive Symptom severity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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
Investigators
Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance

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 Posted: September 27, 2005    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
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