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

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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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name