Trial Outcomes & Findings for Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction (NCT NCT03019887)

Results Overview

The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

Results posted on

2021-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Reduction patients who reduced dose of antipsychotics
Overall Study STARTED	139
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reduction Group n=130 Participants Group of patients with schizophrenia undergoing high-dose therapy (\>1000-mg chlorpromazine eq./day) We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day.
Age, Continuous	51.5 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Region of Enrollment Japan	130 participants n=5 Participants

PRIMARY outcome

Timeframe: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

Population: patients with schizophrenia taking more than 1000 mg / day of antipsychotics, reduce their dose to less than 1000 mg

The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.

Outcome measures

Outcome measures
Measure	Dose Reduction n=130 Participants patients who reduced dose of antipsychotics
Number of Participants With Relapse	130 Participants

Adverse Events

Dose Reduction

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dose Reduction n=130 participants at risk patients who reduced dose of antipsychotics
Psychiatric disorders increase in the total PANSS score from baseline	39.2% 51/130
Psychiatric disorders increase in total DIEPSS score	0.00% 0/130
Psychiatric disorders violent behavior	11.5% 15/130

Additional Information

Dr. Ryota Ataniya

Okada hospital

Phone: +81-4-7124-6151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place