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Olanzapine versus sodium valproate for the management of aggression in methadone maintenance treatment

Olanzapine versus sodium valproate for the management of aggression in methadone maintenance treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT138801241457N5
Enrollment
53
Registered
2010-06-15
Start date
2008-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Heroin Withdrawal. Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Olanzapine, 5-15 mg/day, plus placebo of sodium valproate for 12 weeks. Intervention 2: Sodium valproate, 600-1000 mg/day, plus placebo of Olanzapine for 12 weeks.
Treatment - Drugs
Olanzapine, 5-15 mg/day, plus placebo of sodium valproate for 12 weeks
Sodium valproate, 600-1000 mg/day, plus placebo of Olanzapine for 12 weeks

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Methadone Maintenance Treatment, at least one month negative morphine test, age 18 to 55 years old Exclusion Criteria: Axis I Diagnosis of mental disorders, Diabetes Mellitus or impaired glucose tolerance test, Hyperlipidemia, Hepatic Diseases, abnormal CBC, Positive pregnancy test for women

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Aggression. Timepoint: weekly for 12 weeks. Method of measurement: Modified Overt Aggression Scale.

Secondary

MeasureTime frame
Relapse rate, and side effects. Timepoint: randomly, 1 to 8 times per month urine test for relapse rate; and weekly evaluation of side effects. Method of measurement: urine test for relapse evaluation; and physical and mental status examination for side effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehran Zarghami

Mazandaran University of Medical Sciences

mehran.zarghami@gmail.com & mzarghami@mazums.ac.ir+98 15 1226 3763

Outcome results

None listed

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