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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amisulpride Group | Experimental | The patients will receive low dose Amisulpride at 100-300 mg/day. |
|
| Olanzapine-Fluoxetine Group | Active Comparator | the patients will receive Olanzapine-Fluoxetine Combinations at 5/10 + 20 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride | Drug | low dose of Amisulpride at 100-300 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Serum BDNF Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biswa R Mishra, MD | All India Institute of Medical Sciences, Bhubaneswar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Bhubaneswar | Odisha | DR BISWA RANJAN MISHRA | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3630758 | Background | 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. | |
| 4637572 | 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. |
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To maintain the confidentiality of the participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amisulpride Group | The patients received Amisulpride at 100-300 mg/day. Amisulpride: Amisulpride at 100-300 mg/day |
| FG001 | Olanzapine-Fluoxetine Group | the patients received Olanzapine-Fluoxetine Combinations at 5/10-5/20 mg/day. Olanzapine-Fluoxetine Combination: Olanzapine (5 mg/day) and Fluoxetine (10-20 mg/day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amisulpride Group | Received Amisulpride at 100-300 mg/day |
| BG001 | Olanzapine-Fluoxetine Group | Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amisulpride Group | Received Amisulpride at 100-300 mg/day | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Biswa Ranjan Mishra | All India Institute of Medical Sciences | 09438884220 | psych_biswa@aiimsbhubaneswar.edu.in |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 1, 2019 | Apr 3, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| C492572 | olanzapine-fluoxetine combination |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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Randomized, parallel-group, rater-blinded, clinical trial.
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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
| Olanzapine-Fluoxetine Combination | Drug | Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day) |
|
|
The change in serum BDNF levels in the study groups at 8 weeks (in pg/mL) |
| 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]. | 8 week |
| Adverse Drug Reactions | Detect adverse drug reactions (if any) and grading their severity | 8 weeks |
| 28503978 | 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. |
| 12785461 | 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. |
| 2278986 | 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. |
| 14642970 | 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. |
| 20334574 | 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. |
| 38560960 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| PANSS-P score | The Positive and Negative Syndrome Scale - Positive (PANSS-P) is a medical scale that measures the severity of positive symptoms of schizophrenia. It has seven items (delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility). Each item has a score range of 1 to 7. Thus, the total minimum score is 7, and the total maximum score is 49. Higher scores mean more severity of symptoms. | Mean | Standard Deviation | score on a scale |
|
| MADRS score | The Montgomery-Asberg Depression Rating Scale (MADRS) is a ten-item scale used to measure the severity of depressive symptoms in a patient. Each item has a score ranging from 0 to 6. Thus, the total minimum score is 0, and the total maximum score is 60. The higher the score, the more severe the depressive symptoms. | Mean | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | Serum BDNF Levels | The change in serum BDNF levels in the study groups at 8 weeks (in pg/mL) | Posted | Mean | Standard Error | picograms per milliliter | 8 weeks |
|
|
|
| Secondary | 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]. | Posted | Number | r (correlation coefficient) | 8 week |
|
|
|
| Secondary | Adverse Drug Reactions | Detect adverse drug reactions (if any) and grading their severity | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Olanzapine-Fluoxetine Group | Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day) | 0 | 30 | 0 | 30 | 0 | 30 |
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| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |