Phase 4
Completed N=60
Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression
Post-Schizophrenic Depression
Source: ClinicalTrials.gov NCT04876521 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Calgary Depression Scale for Schizophrenia (CDSS) — 8.31; 8.62 score on a scale
◆ Published Evidence
Emerging
2citations · ~1 / year
Efficacy and safety of low-dose amisulpride versus olanzapine-fluoxetine combination in post-schizophrenic depression: A randomized controlled trial.
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.
Linked Publications
-
Efficacy and safety of low-dose amisulpride versus olanzapine-fluoxetine combination in post-schizophrenic depression: A randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calgary Depression Scale for Schizophrenia (CDSS) |
8.31; 8.62 | — |
| SECONDARY Clinical Global Impression - Severity (CGI) Scale |
3.31; 3.44 | — |
| SECONDARY Serum BDNF Levels |
1453.59; 1471.19 | — |
| SECONDARY Correlation |
-0.161; -0.123 | — |
| SECONDARY Adverse Drug Reactions |
0; 0 | — |
Eligibility Criteria
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
- Patients with a past history of primary depression
- Patients already on Olanzapine-Fluoxetine combination or Amisulpride
Data sourced from ClinicalTrials.gov (NCT04876521) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.