Trial Outcomes & Findings for Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression (NCT NCT04876521)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Amisulpride Group The patients received Amisulpride at 100-300 mg/day. Amisulpride: Amisulpride at 100-300 mg/day	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)
Overall Study STARTED	30	30
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amisulpride Group n=30 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=30 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)	Total n=60 Participants Total of all reporting groups
Age, Continuous	35.2 years STANDARD_DEVIATION 10.1 • n=30 Participants	35.4 years STANDARD_DEVIATION 9.8 • n=30 Participants	35.3 years STANDARD_DEVIATION 9.9 • n=60 Participants
Sex: Female, Male Female	13 Participants n=30 Participants	12 Participants n=30 Participants	25 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	18 Participants n=30 Participants	35 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
PANSS-P score	13.70 score on a scale STANDARD_DEVIATION 4.44 • n=30 Participants	13.80 score on a scale STANDARD_DEVIATION 4.22 • n=30 Participants	13.75 score on a scale STANDARD_DEVIATION 4.29 • n=60 Participants
MADRS score	23.17 score on a scale STANDARD_DEVIATION 6.49 • n=30 Participants	23.73 score on a scale STANDARD_DEVIATION 6.82 • n=30 Participants	23.45 score on a scale STANDARD_DEVIATION 6.61 • n=60 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Amisulpride Group n=25 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=23 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)
Calgary Depression Scale for Schizophrenia (CDSS)	8.31 score on a scale Standard Error 0.47	8.62 score on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Amisulpride Group n=25 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=23 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)
Clinical Global Impression - Severity (CGI) Scale	3.31 units on a scale Standard Error 0.09	3.44 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: 8 weeks

The change in serum BDNF levels in the study groups at 8 weeks (in pg/mL)

Outcome measures

Outcome measures
Measure	Amisulpride Group n=25 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=23 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)
Serum BDNF Levels	1453.59 picograms per milliliter Standard Error 44.62	1471.19 picograms per milliliter Standard Error 48.22

SECONDARY outcome

Timeframe: 8 week

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 \[where +/- 1 mean strongest correlation and 0 mean no correlation\].

Outcome measures

Outcome measures
Measure	Amisulpride Group n=25 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=23 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)
Correlation	-0.161 r (correlation coefficient)	-0.123 r (correlation coefficient)

SECONDARY outcome

Timeframe: 8 weeks

Detect adverse drug reactions (if any) and grading their severity

Outcome measures

Outcome measures
Measure	Amisulpride Group n=25 Participants Received Amisulpride at 100-300 mg/day	Olanzapine-Fluoxetine Group n=23 Participants Received Olanzapine-Fluoxetine Combination: Olanzapine (5-10 mg/day) and Fluoxetine (20 mg/day)
Adverse Drug Reactions	0 Participants	0 Participants

Adverse Events

Amisulpride Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olanzapine-Fluoxetine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Biswa Ranjan Mishra

All India Institute of Medical Sciences

Phone: 09438884220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place