Status:
COMPLETED
Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Post-Schizophrenic Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Post-Schizophrenic Depression (PSD) increases the morbidity and mortality of Schizophrenic patients. Hence, it warrants early assessment and intervention. But, clinical trials on PSD are very few. How...
Detailed Description
The proposed study would be an 8-week, randomized, controlled, parallel-group, clinical trial which will be conducted at the Inpatient and Outpatient settings of the Department of Psychiatry, AIIMS, B...
Eligibility Criteria
Inclusion
- Patients with Post Schizophrenic Depression according to ICD10-DCR (International Classification of Diseases 10- Diagnostic Criteria for Research).
- Aged between 18 to 60 years of either sex
- Patients with a positive score of less than 29 on the Positive and Negative Syndrome Scale (PANSS) \[88\]
- Patients with a score of more than 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) \[89-90\]
- Patients without Extrapyramidal symptoms: a score of less than 3 on the Simpson-Angus Scale \[91\]
- With Informed consent from the Legally Authorised Relative
Exclusion
- Patients with a medical or neurological disorder
- Patients with a history of substance dependence
- Patients with high suicidality
- Patients with a past history of primary depression
- Patients already on Olanzapine-Fluoxetine combination or Amisulpride
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04876521
Start Date
October 14 2019
End Date
June 30 2021
Last Update
September 19 2024
Active Locations (1)
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1
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, DR BISWA RANJAN MISHRA