MedPath

Comparing efficacy of ECT with and without concurrent sodium valproate therapy in manic patients

Not Applicable
Conditions
Manic episode of bipolar disorder.
Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms
F31.1 and
Registration Number
IRCT138901161743N3
Lead Sponsor
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
42
Inclusion Criteria

obtaining informed consent, Diagnosis of bipolar I disorder, manic episode, must be confirmed according to DSM IV-TR criteria, Manic episode refractory to pharmacotherapy, receiving therapeutic doses of valproate before ECT for at least 5 days, Serum levels of valproate =50 µg/ml, Administration of ECT by attending psychiatrist, age 18-60 years
Exclusion criteria: Uncontrolled physical condition, Pregnant and nursing women, LFT: 3 fold greater than upper normal limits, receiving other anticonvulsant medications, History of epilepsy

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement rate of mania. Timepoint: after second, fourth, sixth and at the end of sessions of ECT. Method of measurement: CGI and YMRS.
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath