NCT00186186

Brief Summary

The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

September 13, 2005

Results QC Date

May 12, 2014

Last Update Submit

March 1, 2017

Conditions

Depression, Bipolar

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRS)

    The Montgomery-Ã…sberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

    Baseline, 7 weeks

Secondary Outcomes (1)

  • Response to the Divalproex-ER in Acute Bipolar 2 Depression.

    7 weeks

Study Arms (1)

Depakote ER

EXPERIMENTAL

Depakote ER up to 1500 mg/day

Drug: Depakote ER

Interventions

Depakote ERDRUG

Depakote ER

Depakote ER

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar I, II or NOS currently suffering from depression
  • Both: both female and male participants are being studied
  • Adults 18 years and older of any race

You may not qualify if:

  • Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion
  • Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study.
  • Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, as long as dependence and abuse are ruled out according to DSM-IV)
  • Significant risk harm to self or others based on history and mental status exam
  • Clinically significant or unstable medical condition
  • Unstable thyroid pathology and treatment initiated or altered within the past 3 months
  • Clinically significant abnormal laboratory test results, vital signs, as judged by the investigators
  • Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception
  • Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Bipolar Disorders Clinic

Stanford, California, 94305-5723, United States

Location

Related Publications (1)

  • Wang PW, Nowakowska C, Chandler RA, Hill SJ, Nam JY, Culver JL, Keller KL, Ketter TA. Divalproex extended-release in acute bipolar II depression. J Affect Disord. 2010 Jul;124(1-2):170-3. doi: 10.1016/j.jad.2009.10.021.

    PMID: 19923006RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Limitations and Caveats

This trial is limited by small sample size, as well as an open-label study design with no placebo control.

Results Point of Contact

Title
Dr. Terence Ketter, Chief Bipolar Disorder Clinic
Organization
Stanford University
tketter@stanford.edu
650-723-2515

Study Officials

  • Terence A. Ketter, MD

    Stanford University, Department of Psychiatry and Behavioral Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professot

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 12, 2017

Results First Posted

April 12, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)