UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012574 |
|---|---|
| Receipt number | R000014153 |
| Scientific Title | An open-label study evaluating the effectiveness of aripiprazole for schizophrenia patients with dopamine supersensitivity psychosis. |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2019/06/28 13:57:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An open-label study evaluating the effectiveness of aripiprazole for schizophrenia patients with dopamine supersensitivity psychosis.
Acronym
Alpha-PROGRESS trial
Scientific Title
An open-label study evaluating the effectiveness of aripiprazole for schizophrenia patients with dopamine supersensitivity psychosis.
Scientific Title:Acronym
Alpha-PROGRESS trial
Region
| Japan |
Condition
Condition
Schizophrenia, Schizaffective disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and tolerability of 2-year pahased-in aripiprazole treatment for schizophrenia/schizoaffective disorder patients with on-going dopamine supersensitivity psychosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive and Negative Syndrome Scale(PANSS: Kay et al., 1981)
Key secondary outcomes
Global Assessment of Functioning (GAF)
Clinical Global Impression Scale-Severity/-Change
Extrapyramidal Symptom Rating Scale (ESRS: Chouinard and Margolese, 2005)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aripiprazole is added with 1.5-mg/day increases every 14 days, in case adjustment of the drug regimen is necessary, during the first and second step as follows.
1. The first step is the aripiprazole add-on phase. In this phase, 1.5 mg/day aripiprazole is adjunctively added onto previous antipsychotic(s) in each study participant. At the end of the 4th week following the study initiation, 3 mg/day aripiprazole is continued. Addition of any other neuroleptic(s) or reduction of other prescription neuroleptic(s) is not allowed during the phase.
2. The second step is the aripiprazole switching phase. In this phase, slow titration every 14 days, with further addition of 1.5 mg/day aripiprazole and concomitant reduction of other neuroleptic(s) is conducted. The reduced dosage of the other neuroleptic(s) is determined as the dose corresponding to aripiprazole 1.5 mg. That is, the total chlorpromazine-equivalent dosage do not increase or decrease in the switching procedure. If further tapering of other neuroleptic(s) is possible under careful clinical observation, more reduction in the total dose relative to the dose at the study initiation and/or further switching to aripiprazole monotherapy (i.e., all of other neuroleptics are tapered off) is recommended. The clinician directed this switching and adjustment process based on the participant's clinical status, until the best drug dose of both aripiprazole (max. dose is 30 mg/day) and other neuroleptic(s) are fixed.
3. The third step is the aripiprazole observational phase. The fixed drug combination therapy or aripiprazole monotherapy is continued up to the 24th month after the study initiation. If any drug adjustment is clinically necessary, a dose alteration of aripiprazole and/or other taken antipsychotic(s) is allowed. However, addition of a new neuroleptic(s) is impossible.
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Satisfaction of DSM-4-TR criteria for schizophrenia (295.XX) or schizoaffective disorder (295.70).
2)Occurence of at least one episode of dopamine supersensitivity psychosis as follows, within the prior year.
A)Acute relapse or exacerbation of psychosis appearing after a dose reduction or discontinuation of antipsychotics, within 6 weeks for oral medication or 3 months for intramuscular medication.
B)Development of tolerance to antipsychotic effects. This is defined as when an acute relapse or exacerbation of psychosis occurs, independent of a dose reduction or discontinuation of antipsychotic therapy and stable psychotic state.
C)Relapse episodes cannot be successfully controlled by a 20% increased titration of drug.
D)Psychotic symptoms which are new to the patient, or of greater severity, occuring immediately after a decrease in drug dosage.
3)Age at the consent to study participation within the range of 20 to 60 years.
4)No alteration of content/dosage/usage of taken antipsychotics in the 4 weeks prior to the study initiation.
5)The patient himself/herself understands all of the study content and agrees the study particiation with a written informed consent. If the study physician judges that the patients cannot understand the study due to his/her disease status, written consent by his/her guardian such as parent or spouse is possible.
Key exclusion criteria
1)Under treatment with clozapine
2)A treatment history of ECT in the 3 months prior to the study enrollment
3)In a coma state
4)Under profound effects by CNS inhibition drugs such as barbiturates or anesthetic agent
5)Under treatment with adrenergic agent
6)Hypersensitivity to any content in the trial drug
7)Lacking notification of diagnosis
8)Presence of any other Axis 1 or 2 psychiatric disorder according to DSM-4-TR
9)Pregnant or suspected of pregnancy
10)Participation history of a clinical trial with any intervention (i.e., except for observational study), within recent 3 months prior to the study enrollment
11)With suicide history within the 1 year proor to the study enrollment
12)Assessment as unsuitable for participation in the study by the study physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, 260-8670, Japan
TEL
043-222-7171
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Kanahara |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of Medical Treatment and rehabilitation
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, 260-8670, Japan
TEL
043-222-7171
Homepage URL
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
千葉大学医学部附属病院（千葉県）、千葉県精神科医療センター（千葉県）、同和会千葉病院（千葉県）、さつき会袖ケ浦さつき台病院（千葉県）、同仁会木更津病院（千葉県）、成田赤十字病院（千葉県）、白百合会市原鶴岡病院（千葉県）、澄心会茂原神経科病院（千葉県）、更生会草津病院（広島県）、生仁会須田病院（岐阜県）、別府医療センター（大分県）、松坂厚生病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 03 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014153
