Schizophrenia RelapseNCT03019887
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
A study testing reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine in people with Schizophrenia Relapse, run by Juntendo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Schizophrenia Relapse
- What is being tested?
- reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatients with a diagnosis of schizophrenia, and
- those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.
Who cannot join
- 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
About this study
Official title: Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.
Read the detailed description
We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.
- Conditions
- Schizophrenia Relapse
- Being tested
- reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazineDrug
| Study group | Role | What they receive |
|---|---|---|
| reduction group | Experimental | dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week Receives: Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startApr 2011
- Primary completionJan 2017
- Study completionJan 2017
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.
- Other trials for Schizophrenia RelapseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juntendo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryota Ataniya, Juntendo University
- Investigators
- Takahashi Tadashi, Study chair, Okada hospitalMikiro Saito, Study chair, Okada hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019887
- Sponsor's protocol ID
- 673
- Status last verified
- Aug 2021
- First submitted
- 11 Jan 2017
- Last updated
- 9 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy
- ClinicalTrials.gov ID
- NCT03019887
- Acronym / sponsor ID
- 673
- Conditions
- Schizophrenia Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Juntendo UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.
Detailed description
We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reduction group | Experimental | Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazinedose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inpatients with a diagnosis of schizophrenia, and
- those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine | Drug | reduction group |
Primary outcome
Number of Participants With Relapse
Time frame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takahashi Tadashi study chair
Okada hospital
Mikiro Saito study chair
Okada hospital
Questions about this trial
What is this clinical trial studying?
A study testing reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine in people with Schizophrenia Relapse, run by Juntendo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Relapse (time frame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.