Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression

NCT04876521 | Completed Phase 4 Results

• 1 other identifier: AIIMS BBSR/PGThesis/2019-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Post-Schizophrenic Depression

Keywords

Post-Schizophrenic Depression; Amisulpride; Olanzapine-Fluoxetine Combination; Post Psychotic Depression

Outcome Measures

Primary Outcomes (1)

• Calgary Depression Scale for Schizophrenia (CDSS)

  Calgary Depression Scale for Schizophrenia (CDSS) scores is used to measure the severity of depressive symptoms in the study groups. The total score ranges from 0 - 36. Higher scores represent a higher severity of depression.

  8 weeks

Secondary Outcomes (4)

• Clinical Global Impression - Severity (CGI) Scale

  8 weeks

• Serum BDNF Levels

  8 weeks

• Correlation

  8 week

• Adverse Drug Reactions

  8 weeks

Study Arms (2)

Amisulpride Group

EXPERIMENTAL

The patients will receive low dose Amisulpride at 100-300 mg/day.

Drug: Amisulpride

Olanzapine-Fluoxetine Group

ACTIVE COMPARATOR

the patients will receive Olanzapine-Fluoxetine Combinations at 5/10 + 20 mg/day.

Drug: Olanzapine-Fluoxetine Combination

Interventions

Amisulpride DRUG

low dose of Amisulpride at 100-300 mg/day

Also known as: Sulpitac, Amazeo, Soltus

Amisulpride Group

Olanzapine-Fluoxetine Combination DRUG

Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)

Also known as: Oleanz Fort, Oleanz Plus

Olanzapine-Fluoxetine Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, DR BISWA RANJAN MISHRA, India

Location

Related Publications (8)

• Berrios GE, Bulbena A. Post psychotic depression: the Fulbourn cohort. Acta Psychiatr Scand. 1987 Jul;76(1):89-93. doi: 10.1111/j.1600-0447.1987.tb02866.x.

  PMID: 3630758 BACKGROUND

• Stern MJ, Pillsbury JA, Sonnenberg SM. Postpsychotic depression in schizophrenics. Compr Psychiatry. 1972 Nov-Dec;13(6):591-8. doi: 10.1016/0010-440x(72)90060-0. No abstract available.

  PMID: 4637572 BACKGROUND

• Rahim T, Rashid R. Comparison of depression symptoms between primary depression and secondary-to-schizophrenia depression. Int J Psychiatry Clin Pract. 2017 Nov;21(4):314-317. doi: 10.1080/13651501.2017.1324036. Epub 2017 May 15.

  PMID: 28503978 BACKGROUND

• Whitehead C, Moss S, Cardno A, Lewis G. Antidepressants for the treatment of depression in people with schizophrenia: a systematic review. Psychol Med. 2003 May;33(4):589-99. doi: 10.1017/s0033291703007645.

  PMID: 12785461 BACKGROUND

• Addington D, Addington J, Schissel B. A depression rating scale for schizophrenics. Schizophr Res. 1990 Jul-Aug;3(4):247-51. doi: 10.1016/0920-9964(90)90005-r.

  PMID: 2278986 BACKGROUND

• Moller HJ. Amisulpride: limbic specificity and the mechanism of antipsychotic atypicality. Prog Neuropsychopharmacol Biol Psychiatry. 2003 Oct;27(7):1101-11. doi: 10.1016/j.pnpbp.2003.09.006.

  PMID: 14642970 BACKGROUND

• Bocchio-Chiavetto L, Bagnardi V, Zanardini R, Molteni R, Nielsen MG, Placentino A, Giovannini C, Rillosi L, Ventriglia M, Riva MA, Gennarelli M. Serum and plasma BDNF levels in major depression: a replication study and meta-analyses. World J Biol Psychiatry. 2010 Sep;11(6):763-73. doi: 10.3109/15622971003611319.

  PMID: 20334574 BACKGROUND

• Biswas T, Mishra BR, Maiti R, Padhy SK, Mishra A. Efficacy and safety of low-dose amisulpride versus olanzapine-fluoxetine combination in post-schizophrenic depression: A randomized controlled trial. J Psychiatr Res. 2024 May;173:302-308. doi: 10.1016/j.jpsychires.2024.03.048. Epub 2024 Mar 28.

  PMID: 38560960 DERIVED

MeSH Terms

Interventions

Amisulpride; olanzapine-fluoxetine combination

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

1. Small sample size 2. Single-center study 3. No control arm for comparing the Serum BDNF levels

Results Point of Contact

• Title: Dr. Biswa Ranjan Mishra
• Organization: All India Institute of Medical Sciences

psych_biswa@aiimsbhubaneswar.edu.in

09438884220

Study Officials

• Biswa R Mishra, MD

  All India Institute of Medical Sciences, Bhubaneswar

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The proposed study will be rater-blinded. The ratings would be done by a psychiatrist who would be blinded to the nature of the intervention provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor, Department of Psychiatry

Model Details: Randomized, parallel-group, rater-blinded, clinical trial.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: October 14, 2019
• Primary Completion: June 9, 2021
• Study Completion: June 30, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)