Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression
Status:
Recruiting
Trial end date:
2022-05-04
Target enrollment:
Participant gender:
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. However, an Antipsychotic with an adjunctive Antidepressant (like
Olanzapine-Fluoxetine Combination) is the commonly prescribed treatment in PSD. Low dose
Amisulpride (<400 mg/day) which is effective against the negative symptoms of Schizophrenia
has also proved efficacious in treating depression in non-psychotic conditions, but its
antidepressant property has never been studied in PSD. This is an 8-week, randomized,
parallel-group study that will explore the efficacy and safety of low-dose Amisulpride versus
Olanzapine-Fluoxetine Combination in the treatment of PSD. Our hypothesis is that low dose
Amisulpride has better efficacy and safety versus Olanzapine-Fluoxetine Combination in PSD,
after 8-weeks.
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar