Baclofen use in patients with schizophrenia

The effect of baclofen on positive and negative symptoms in patients with schizophrenia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250312065047N1

Enrollment

144

Registered

2025-03-21

Start date

2025-04-04

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: Baclofen (Chemi Darou Industrial Company) (starting at 5 mg per day and gradually increasing to 20 mg per day over the first week) for 8 weeks. Intervention 2: Cont

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Under treatment with risperidone Diagnosis of schizophrenia No clear brain damage At least 2 years have passed since the onset of schizophrenia

Exclusion criteria

Exclusion criteria: Use of typical and atypical antipsychotic medications Presence of comorbid psychiatric disorders Dependence or abuse of substances, medications, or alcohol Occurrence of side effects

Design outcomes

Primary

Measure	Time frame
Structured Clinical Interview for DSM. Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Positive and Negative Syndrome Scale (PANSS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Calgary Depression Scale for Schizophrenia (CDSS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Abnormal Involuntary Movement Scale (AIMS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.	—

Measure

Time frame

Structured Clinical Interview for DSM. Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Positive and Negative Syndrome Scale (PANSS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Calgary Depression Scale for Schizophrenia (CDSS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.;Abnormal Involuntary Movement Scale (AIMS). Timepoint: Before intervention, weeks 2, 4, and 8. Method of measurement: Questionary.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Pourshams

Ahvaz University of Medical Sciences

pourshams-m@ajums.ac.ir+98 61 3311 0000

Outcome results

None listed

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