Open trial addition of divalproex sodium in improving the symptoms of Batak and Non Batak males with schizophrenia in North Sumatra, Indonesia

Phase 3

Completed

• Conditions: Batak and Non-Batak male patients with schizophrenia; Mental and Behavioural Disorders; Schizophrenia

• Registration Number: ISRCTN16522451
• Lead Sponsor: niversity of Sumatera Utara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-26
• Study Start: 2019-03-06
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Age range of 20-45 years
2. Schizophrenia for over 2 years
3. PANSS total score between 80-150 (acute phase of treatment)
4. Body weight < 65 kg

Exclusion Criteria

1. PANSS Excited Component (PANSS EC) >20
2. History of chronic medical disease
3. History of substance use (except caffeine and nicotine)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Schizophrenia symptoms measured using PANSS scores at baseline and every weeks for 6 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse effects such as gastrointestinal complaints, tremor observed every day every week for 6 weeks