Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

NCT03019887 | Completed Results

• 1 other identifier: 673
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

Brief Summary

To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

Conditions

Schizophrenia Relapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse

  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.

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

Study Arms (1)

reduction group

EXPERIMENTAL

dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week

Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

Interventions

reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine DRUG

reduction group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatients with a diagnosis of schizophrenia, and
• those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.

You may not qualify if:

• mental retardation,
• substance abuse or dependence,
• a history of major head trauma,
• serious medical or neurological disorders, or
• depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months

Sponsors & Collaborators

• Juntendo University: lead

MeSH Terms

Interventions

Haloperidol; Olanzapine; Quetiapine Fumarate; Aripiprazole; Paliperidone Palmitate; Methotrimeprazine; Perphenazine

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Piperazines; Heterocyclic Compounds, 1-Ring; Quinolones; Quinolines; Isoxazoles; Azoles; Pyrimidines; Phenothiazines

Results Point of Contact

• Title: Dr. Ryota Ataniya
• Organization: Okada hospital

ryotaataniya@pbt.nir.jp

+81-4-7124-6151

Study Officials

• Takahashi Tadashi

  Okada hospital

  STUDY CHAIR

• Mikiro Saito

  Okada hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician, graduate student

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: April 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-08