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 TRIA
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2021/10/037493
- Lead Sponsor
- Dr Sharon Narula
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the change in the severity of negative <br/ ><br>symptoms of schizophrenia in terms of change in <br/ ><br>PANSS scores in the study groups over 24 weeksTimepoint: baseline , 12 weeks, 24 weeks
- Secondary Outcome Measures
Name Time Method 1. To evaluate the change in symptom severity and <br/ ><br>improvement in terms of change in Clinical <br/ ><br>Global Impression (CGI) scores in the study <br/ ><br>groups over 24 weeks <br/ ><br>2. To evaluate the change in terms of change in The <br/ ><br>Montreal Cognition Assessment (MoCA) scores <br/ ><br>in the study groups over 24 weeksTimepoint: baseline , 12 weeks, 24 weeks