A Clinical trial to study the effects of Intranasal Oxytocin Therapy for Treatmentof Negative Symptoms in Schizophrenia
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecifiedHealth Condition 2: F203- Undifferentiated schizophrenia
- Registration Number
- CTRI/2023/12/060817
- 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
1) Schizophrenia diagnosed patients according to The ICD 11 Classification of Mental and Behavioural Disorders, Diagnostic criteria for research.
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.
8
6) CDSS score <6 and SAS score <3 to rule out secondary negative symptoms.
7) Patients receiving treatment for schizophrenia with preferably second generation anti-psychotic
8) No substance use or addiction (except nicotine and caffeine)
9) No medical co-morbidities.
10) Signed informed consent.
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) Allergic rhinitis or other inflammation of nasal mucosa for past 6 months
6) Patients receiving treatment with any first-generation anti-psychotic/depot or long-acting anti-psychotic/anti-depressant.
7) Not willing to give written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method