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

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ClinicalTrials.gov Identifier: NCT04876521
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-Schizophrenic Depression Drug: Amisulpride Drug: Olanzapine-Fluoxetine Combination Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, parallel-group, rater-blinded, clinical trial.
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety of Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in the Treatment of Post Schizophrenic Depression: A Randomized Controlled Trial
Actual Study Start Date : May 4, 2021
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : May 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. Serum BDNF levels [ Time Frame: 8 weeks ]
    The change in serum BDNF levels in the study groups over 8 weeks

  3. Correlation [ Time Frame: 8 week ]
    Determine the correlation (if any) between the between changes in CDSS scores, CGI scores and serum BDNF levels

  4. Adverse drug reactions [ Time Frame: 8 weeks ]
    Detect adverse drug reactions (if any) and grading their severity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04876521


Contacts
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Contact: Rituparna Maiti, MD 9438884191 pharm_rituparna@aiimsbhubaneswar.edu.in
Contact: Tathagata Biswas, MBBS 9735177798 drtatz92@gmail.com

Locations
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India
All India Institute of Medical Sciences Recruiting
Bhubaneswar, Orissa, India, DR BISWA RANJAN MISHRA
Contact: Rituparna Maiti, MD    9438884191    pharm_rituparna@aiimsbhubaneswar.edu.in   
Contact: Tathagata Biswas, MBBS    9735177798    drtatz92@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Principal Investigator: Biswa R Mishra, MD All India Institute of Medical Sciences, Bhubaneswar
More Information
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Publications:

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Responsible Party: BISWA RANJAN MISHRA, Additional Professor, Department of Psychiatry, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT04876521    
Other Study ID Numbers: AIIMS BBSR/PGThesis/2019-21
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It will be discussed among investigators later.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar:
Post-Schizophrenic Depression
Amisulpride
Olanzapine-Fluoxetine Combination
Post Psychotic Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Olanzapine
Amisulpride
Fluoxetine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Dopamine Antagonists
Dopamine Agents