UMIN-CTR Clinical Trial

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
Email	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
Email	kanahara@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014153