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Cariprazine as an adjunct therapy for treatment of negative symptoms in patients with Schizophrenia

Phase 3
Conditions
Health Condition 1: F20- Schizophrenia
Registration Number
CTRI/2024/07/070875
Lead Sponsor
Central Institute of Psychiatry
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) Schizophrenia diagnosed patients according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, ICD-10 Diagnostic criteria.

2) 20–55 years of age.

3) Disease course >2years.

4) PANSS negative symptoms score =4 in at least four items or =15 combined.

5) PANSS positive symptoms score =4 in at least three items or =10 combined.

6) CDSS score <6 and SAS score <3

7) Patients receiving treatment for schizophrenia with preferably second generation anti¬-psychotic

8)Those who give informed consent for

participating in the study.

Exclusion Criteria

1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.

2.Significant medical or neurological illness including severe cardiovascular, hepatic, renal, [serum creatinine > 1.5 mg/dl], anaemia [Haemoglobin < 11 mg/dl], or myopathy or untreated thyroid disease.

3.History of substantial brain damage or any neurological disorders.

4.Pregnancy

5.Patients receiving treatment with any first-generation anti-psychotic / depot or long-acting anti-psychotic / anti-depressant.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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