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EFFECTIVENESS OF N-ACETYL CYSTEINE AS AN ADD ON THERAPY IN NEGATIVE AND COGNITIVE SYMPTOMS OF SCHIZOPHRENIA, AN OPEN LABEL 24 WEEKS FOLLOW-UP RANDOMIZED CONTROL TRIAL

EFFECTIVENESS OF N-ACETYL CYSTEINE AS AN ADD ON THERAPY IN NEGATIVE AND COGNITIVE SYMPTOMS OF SCHIZOPHRENIA, A PLACEBO CONTROLLED DOUBLE BLINDED 24 WEEKS FOLLOW-UP RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037493
Enrollment
70
Registered
2021-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: N-acetyl cysteine: Dosage - 600 mg Frequency - Twice daily Route - Per Oral Duration of therapy - 6 months Control Intervention1: Not applicable: Not applicable

Sponsors

Dr Sharon Narula
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients coming for treatment at the OPD and IPD of the Department of Psychiatry fulfilling the following are included: a) Patients with Schizophrenia according to ICD10- DCR (International Classification of Diseases 10â?? Diagnostic Criteria for Research). b) Aged between 18 to 65 years of either sex c) Patients on treatment with Olanzapine on an adequate dose d) With Informed consent from the Legally Authorized Relative

Exclusion criteria

Exclusion criteria: Patients with any one of the following are excluded from the study: a) With a history of head trauma or seizure disorder or neurodevelopmental delay b) On NAC as a medication c) Who are allergic to NAC or any component of it d) Who are taking Selective Serotonin Reuptake Inhibitors (SSRIs) e) Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
To evaluate the change in the severity of negative symptoms of schizophrenia in terms of change in PANSS scores in the study groups over 24 weeksTimepoint: baseline , 12 weeks, 24 weeks—

Secondary

MeasureTime frame
1. To evaluate the change in symptom severity and improvement in terms of change in Clinical Global Impression (CGI) scores in the study groups over 24 weeks 2. To evaluate the change in terms of change in The Montreal Cognition Assessment (MoCA) scores in the study groups over 24 weeksTimepoint: baseline , 12 weeks, 24 weeks—

Countries

India

Contacts

Public ContactDr Sharon Narula

AIIMS Bhubaneswar

psych_susanta@aiimsbhubaneswar.edu.in8249394882

Outcome results

None listed

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