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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16522451
Enrollment
60
Registered
2019-03-06
Start date
2017-09-11
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Batak and Non-Batak male patients with schizophrenia Mental and Behavioural Disorders Schizophrenia

Interventions

Sampling was done by non-probability type consecutive sampling. Each subject who has been willing to be the subject of research and has signed a research agreement will be selected to meet the inclusi
where each subject was present having the same opportunity. It is because of the number of samples in this study was small, namely 60 subjects, which consisted of 30 subjects for the Batak tribe and 3

Sponsors

University of Sumatera Utara
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Schizophrenia symptoms measured using PANSS scores at baseline and every weeks for 6 weeks

Secondary

MeasureTime frame
Adverse effects such as gastrointestinal complaints, tremor observed every day every week for 6 weeks

Countries

Indonesia

Contacts

Public ContactNovi Prasanty
noviprasanty86@gmail.com+62 (0)8116178330

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026