Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression (PSD-AOFC)

May 29, 2021 updated by: BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar

Comparative Efficacy and Safety of Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in the Treatment of Post Schizophrenic Depression: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, Bhubaneswar. Patients with the diagnosis of Post Schizophrenic Depression according to the ICD 10 (DCR) and meeting all the Inclusion and Exclusion Criteria would be selected for the study. At first, the patients and their family members/ guardians would be explained about the study procedure along with its possible risks and benefits using a Patient Information Sheet (in their local language). After obtaining a written Informed Consent from the Legally Authorised Relative, the patients would be finally recruited for the study.

All recruited patients would be randomized using computer-generated random numbers into two treatment groups with an allocation ratio of 1:1. The sociodemographic and clinical data of the patients would be collected as per the designed sheets. Then at baseline, the CDSS and CGI ratings would be assessed, and the serum BDNF would be tested for each patient. The study would be rater-blinded. The experimental group would receive Amisulpride at a low dosage of 100-300 mg/day and the control group would receive a combination of Olanzapine at 5mg or 10 mg/day and Fluoxetine at 20mg/day.

The two groups would be followed for 8 weeks, at the completion of which all the patients would be reassessed. The follow-up assessment would involve a re-evaluation of the CDSS and the CGI scores and the Serum BDNF levels to see for any change. The data thus collected would be analyzed, compared within and in between the study groups and statistical tests would be applied for drawing conclusions. The missing values will be analyzed by an intention-to-treat protocol.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with Post Schizophrenic Depression according to ICD10-DCR (International Classification of Diseases 10- Diagnostic Criteria for Research).
  2. Aged between 18 to 60 years of either sex
  3. Patients with a positive score of less than 29 on the Positive and Negative Syndrome Scale (PANSS) [88]
  4. Patients with a score of more than 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) [89-90]
  5. Patients without Extrapyramidal symptoms: a score of less than 3 on the Simpson-Angus Scale [91]
  6. With Informed consent from the Legally Authorised Relative

Exclusion Criteria:

  1. Patients with a medical or neurological disorder
  2. Patients with a history of substance dependence
  3. Patients with high suicidality
  4. Patients with a past history of primary depression
  5. Patients already on Olanzapine-Fluoxetine combination or Amisulpride

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amisulpride Group
The patients will receive low dose Amisulpride at 100-300 mg/day.
Drug: Amisulpride
low dose of Amisulpride at 100-300 mg/day
Other Names:
  • Sulpitac
  • Amazeo
  • Soltus
Active Comparator: Olanzapine-Fluoxetine Group
the patients will receive Olanzapine-Fluoxetine Combinations at 5/10-5/20 mg/day.
Drug: Olanzapine-Fluoxetine Combination
Olanzapine (5 mg/day) and Fluoxetine (10-20 mg/day)
Other Names:
  • Oleanz Fort
  • Oleanz Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS) scores will be used to measure the change in the severity of depressive symptoms in the study groups from baseline over 8 weeks. the total score ranges from 0 - 36. Higher scores represent higher severity of depression.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression (CGI)
Time Frame: 8 weeks

Clinical Global Impression (CGI) scores will be used to measure the change in illness severity, global functioning and improvement in the study groups from baseline over 8 weeks.

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale [minimum: 1 and maximum 7]: Higher scores means higher severity of disease.

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale [minimum: 1 and maximum 7]: Higher scores means more clinical improvement.
8 weeks
Serum BDNF levels
Time Frame: 8 weeks
The change in serum BDNF levels in the study groups over 8 weeks
8 weeks
Correlation
Time Frame: 8 week
Determine the correlation (if any) between the between changes in CDSS scores, CGI scores and serum BDNF levels
8 week
Adverse drug reactions
Time Frame: 8 weeks
Detect adverse drug reactions (if any) and grading their severity
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Principal Investigator: Biswa R Mishra, MD, All India Institute of Medical Sciences, Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Anticipated)

April 4, 2022

Study Completion (Anticipated)

May 4, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 29, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMS BBSR/PGThesis/2019-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It will be discussed among investigators later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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