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CompletedNCT00226343Updated Apr 18, 2017

Depakote-ER for Depressive and Bipolar Depression

A Phase 4 interventional study of Depakote-ER in Bipolar Disorder, sponsored by Cambridge Health Alliance. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by Cambridge Health Alliance · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

Study is 6 weeks long, with 7 clinical visits.

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Conditions studied

  • Bipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 25 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
25 participants

Interventions

  • DrugDepakote-ER
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What researchers measure

Primary outcomes

  1. Anxiety and Depressive Symptom severity

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, Bauer AD, Fleck J, Filkowski MM, Stan VA, Dunn RT. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry. 2007 Dec;68(12):1840-4. doi: 10.4088/jcp.v68n1203. PubMed 18162014 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00226343
Lead sponsor
Cambridge Health Alliance
Collaborators
Northwestern University
Responsible party
Sponsor
First posted
Sep 27, 2005
Start date
Aug 2003
Primary completion
Jan 2006
Completion
Aug 2006
Last update
Apr 18, 2017

Study contacts

Robert T Dunn, MD, PhD
principal investigator · Cambridge Health Alliance

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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