Evaluating the Effect of Modafinil on Cognitive Function Improvement and Reduction of Negative Symptoms in Patients with Chronic Schizophrenia

Investigating the Effect of Modafinil on Reducing Cognitive Impairments and Negative Symptoms in Patients with Chronic Schizophrenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250804066762N1

Enrollment

Registered

2025-08-15

Start date

2025-09-20

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Schizophrenia. Schizophrenia, unspecified

Interventions

Intervention 1: Intervention group: In this study, the intervention group will receive 100 mg/day of modafinil (manufactured by Tasnim Pharmaceutical Company) alongside standard treatment. If well tol

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Chronic schizophrenia diagnosis (DSM-5/ICD-10) Age 18-65 years Psychiatric/medication stability (3 months) Significant cognitive impairment (confirmed) Persistent negative symptoms (PANSS=20) Informed consent No strong stimulants use No severe neurological disorders

Exclusion criteria

Exclusion criteria: Hypersensitivity to modafinil Pregnancy or lactation Concurrent use of strong stimulants/sedatives Severe cardiovascular diseases Severe hepatic/renal impairment Substance abuse (past 6 months) Active suicidal risk Other major psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Change in total negative symptoms score (PANSS). Timepoint: Base line, week 4, week 8 and week 12. Method of measurement: Positive and Negative Syndrome Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSajjad Hormozi

Zahedan University of Medical Sciences

sajjad.hormozi@zaums.ac.ir+98 54 3351 3778

Outcome results

None listed

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