UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047785 |
|---|---|
| Receipt number | R000054333 |
| Scientific Title | Halved dose of antipsychotics versus symptomatic treatment for relapse in patients with schizophrenia receiving high dose antipsychotic therapy: a randomized single blind trial |
| Date of disclosure of the study information | 2022/05/18 |
| Last modified on | 2024/02/29 17:38:01 |
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Basic information
Public title
A randomized single-blind trial of the therapeutic effects and safety of halved dose antipsychotics for treating relapse in patients with schizophrenia receiving high dose antipsychotic therapy
Acronym
halved dose antipsychotic therapy
Scientific Title
Halved dose of antipsychotics versus symptomatic treatment for relapse in patients with schizophrenia receiving high dose antipsychotic therapy: a randomized single blind trial
Scientific Title:Acronym
halved dose antipsychotic therapy
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the therapeutic effects and safety of halved dose antipsychotic for treating relapse in patients with schizophrenia receiving high dose antipsychotic therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the period from occurrence of relapse until relapse symptom improvement
Key secondary outcomes
Psychiatric symptoms will be evaluated according to the Positive and Negative Syndrome Scale (PANSS), and extrapyramidal symptoms (EPS) according to the Drug-induced Extra-pyramidal Symptoms Scale (DIEPSS) at baseline, at relapse, and after remission. All adverse events that appear will be evaluated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Halve the amount of antipsychotics in patients receiving high-dose antipsychotics. If relapse is determined, the antipsychotic dose will be reduced.
Interventions/Control_2
treatment with symptomatic treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia receiving high-dose antipsychotic therapy
Key exclusion criteria
intellectual disability, neurodevelopmental disorders, organic, including symptomatic, mental disorder, long term depot antipsychotics within 3 months, electroconvulsive therapy within 6 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Ataniya |
Organization
Edogawa hospital
Division name
Department of Psychiatry
Zip code
135-0061
Address
2702, Yamazaki, Noda-shi, Chiba
TEL
4-7124-5511
ryotaataniya@pbt.nir.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Ataniya |
Organization
Edogawa hospital
Division name
Department of Psychiatry
Zip code
278-0022
Address
2702, Yamazaki, Noda-shi, Chiba
TEL
4-7124-5511
Homepage URL
ryotaataniya@pbt.nir.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Institutional Review Board
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
Tel
03-3784-8305
dh-ctrial@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
https://doi.org/10.21203/rs.3.rs-1699376/v1.
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.21203/rs.3.rs-1699376/v1.
Number of participants that the trial has enrolled
54
Results
Among the 54 patients with schizophrenia undergoing high-dose antipsychotic therapy, 29 patients (54%) relapsed, of whom 14 (52%) were in the halved-dose group while 15 (56%) were in the high-dose group. No statistically difference was observed between the two groups (p = 0.89, t = 0.14). Notably, all the patients who relapsed subsequently achieved remission.
Results date posted
| 2024 | Year | 02 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria encompassed participants who were informed about the clinical trial, open to the prospect of reducing antipsychotic medication, and presently in a state of remission while undergoing high-dose antipsychotic therapy. The term high dose was defined as oral therapy with a dose equivalent to 1,000 mg or more of CP.
Participant flow
The protocol received approval from the ethical review board of Showa University (approval number:20H073) and signed informed consent was obtained from all study participants after a verbal and written explanation of the protocol. The participants, who were inpatients at Edogawa Hospital between 2021 and 2022, were enrolled in the study, performed in accordance with the Declaration of Helsinki.
Adverse events
Safety
Adverse events related to the treatment were observed in six patients (43%) in the halved-dose group (including constipation in three patients, headache in two, and dry mouth in two); however, none of these adverse events led to therapy cessation, and all patients achieved to remission. In the high-dose group, adverse events were observed in 10 patients (73%), including fever in two patients, headache in five, vomiting in two, upper respiratory tract infection in two, dysuria in one, and constipation in three patients. However, all of these events either improved or alleviated, and no adverse events were observed that precluded continuation of the clinical trial. Furthermore, in the halved-dose group, one patient with consistently elevated white blood cells from baseline exhibited improvement.
Outcome measures
Primary Outcome
The primary outcome measured in the study was the duration from relapse to remission in the halved-dose and high-dose antipsychotic therapy groups.
Secondary Outcomes
The study's secondary outcomes included post-remission psychiatric symptoms, extrapyramidal symptoms (EPS) attributed to antipsychotics, and adverse events resulting from halved-dose or high-dose antipsychotic therapy. Psychiatric symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS), while EPS was measured using the Drug-induced Extrapyramidal Symptoms Scale (DIEPSS).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054333
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/06/13 | data repository.xlsx |
