Phase 4
Completed N=28
Depakote ER in Bipolar Depression
Depression, Bipolar
Source: ClinicalTrials.gov NCT00186186 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Montgomery Asberg Depression Rating Scale (MADRS) — 14.9 units on a scale — p=<0.00001
◆ Published Evidence
Emerging
13citations · ~1 / year
Divalproex extended-release in acute bipolar II depression.
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.
Linked Publications
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Divalproex extended-release in acute bipolar II depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) |
14.9 | <0.00001 sig |
| SECONDARY Response to the Divalproex-ER in Acute Bipolar 2 Depression. |
11 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00186186) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.