Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression (NCT04876521) | Clinical Trial Compass
CompletedPhase 4
Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression
India60 participantsStarted 2019-10-14
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Patients with a medical or neurological disorder
✕. Patients with a history of substance dependence
✕. Patients with high suicidality
✕
What they're measuring
1
Calgary Depression Scale for Schizophrenia (CDSS)
Timeframe: 8 weeks
Trial details
NCT IDNCT04876521
SponsorAll India Institute of Medical Sciences, Bhubaneswar