Post-Schizophrenic DepressionPhase 4PSD-AOFCNCT04876521

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

A Phase 4 study testing Amisulpride and Olanzapine-Fluoxetine Combination in people with Post-Schizophrenic Depression, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Post-Schizophrenic Depression
What is being tested?: Amisulpride and Olanzapine-Fluoxetine Combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIndia
Study dates: 14 Oct 2019to 30 Jun 2021
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

All India Institute of Medical Sciences
Bhubaneswar, Odisha, DR BISWA RANJAN MISHRA

Other trials in India

About this study

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

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.

Read the 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.

Conditions: Post-Schizophrenic Depression
Being tested: Amisulpride, Olanzapine-Fluoxetine Combination
Keywords: Post-Schizophrenic Depression, Amisulpride, Olanzapine-Fluoxetine Combination, Post Psychotic Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmisulprideDrug
Also called Sulpitac, Amazeo, Soltus
low dose of Amisulpride at 100-300 mg/day
Olanzapine-Fluoxetine CombinationDrug
Also called Oleanz Fort, Oleanz Plus
Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)

Study groups in NCT04876521
Study group	Role	What they receive
Amisulpride Group	Experimental	The patients will receive low dose Amisulpride at 100-300 mg/day. Receives: Drug: Amisulpride
Olanzapine-Fluoxetine Group	Active comparator	the patients will receive Olanzapine-Fluoxetine Combinations at 5/10 + 20 mg/day. Receives: Drug: Olanzapine-Fluoxetine Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (4)

Clinical Global Impression - Severity (CGI) Scale
The Clinical Global Impression - Severity (CGI-S) is a 7-point scale used to measure the severity of the illness in the study groups [minimum: 1 and maximum 7]: Higher scores mean higher severity of disease.
Measured: 8 weeks
Serum BDNF Levels
The change in serum BDNF levels in the study groups at 8 weeks (in pg/mL)
Measured: 8 weeks
Correlation
Determine the correlation (if any) between the changes in CDSS scores and serum BDNF levels. The correlation coefficient is represented as r, with values from -1 to +1 [where +/- 1 mean strongest correlation and 0 mean no correlation].
Measured: 8 week
Adverse Drug Reactions
Detect adverse drug reactions (if any) and grading their severity
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 201930 Jun 2021

First posted6 May 2021
Study start14 Oct 2019
Primary completion9 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Post-Schizophrenic DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, parallel-group, rater-blinded, clinical trial.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04876521
Sponsor's protocol ID: AIIMS BBSR/PGThesis/2019-21
Acronym: PSD-AOFC
Status last verified: Sep 2024
First submitted: 3 May 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: To maintain the confidentiality of the participants.

Publications

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.
PubMed 3630758
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.
PubMed 4637572
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.
PubMed 28503978
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.
PubMed 12785461
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.
PubMed 2278986
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.
PubMed 14642970
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.
PubMed 20334574
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.
PubMed 38560960