Depakote-ER for Depressive and Bipolar Depression

Cambridge Health Alliance25 enrolled

Overview

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.

Study is 6 weeks long, with 7 clinical visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

Depakote-ERDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Anxiety and Depressive Symptom severity

Data from ClinicalTrials.gov

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