Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000516684
Ethics application status
Approved
Date submitted
19/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Switching to aripiprazole from other second-generation antipsychotics.
Scientific title
A randomised phase IV study to compare two rates of dosage tapering, when switching patients to aripiprazole from other atypical antipsychotics for the treatment of schizophrenia and schizoaffective disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenic and schizoaffective disorder 641 0
Condition category
Condition code
Mental Health 714 714 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty patients, who for clinical reasons are being switched from another SGA to aripiprazole, will be asked to consent to being monitored in a research study. While aripiprazole is being increased to a therapeutic dose, slow reduction of their previous atypical antipsychotic will be compared with more rapid reduction. For one week patients will take Aripiprazole 10 mg mane, in addition to their previous SGA at unchanged dose. Then aripiprazole will be increased to 15 mg, while the previous SGA is decreased. Twenty will undergo slow tapering, the dose decreasing by 2.5 mg olanzapine (or equivalent) weekly. Twenty will undergo more rapid tapering, the dose being decreased by 5 mg olanzapine (or equivalent) weekly. The two tapering strategies will be assigned randomly. Two mg risperidone, 75 mg quetiapine and 400 mg amisulpride are considered to be equivalent to 5 mg olanzapine (Woods, 2003). Patients will be seen before each weekly reduction, to ensure that there is no contraindication to the change. There will be an option to increase aripiprazole to 30 mg according to clinical response, but this dose will not usually be given until the tapered dose is olanzapine 5 mg (or equivalent).
Intervention code [1] 646 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 875 0
Compare over 12 weeks the benefits of tapering atypical antipsychotics rapidly or slowly, while taking aripiprazole 10-30 mg mane.
Timepoint [1] 875 0
Primary outcome [2] 876 0
Compare over 12 weeks the risks of tapering atypical antipsychotics rapidly or slowly, while taking aripiprazole 10-30 mg mane.
Timepoint [2] 876 0
Secondary outcome [1] 1737 0
Assess the side effects and changes in mental state weekly during tapering and thereafter. This will ensure that medication changes do not lead to relapse or unacceptable side effects. Although both tapers are expected to avoid relapse of psychotic symptoms, the hypothesis is that the slow taper will be accompanied by fewer side effects.
Timepoint [1] 1737 0
Weekly
Secondary outcome [2] 1738 0
Assess weight, and other complications of obesity. The hypothesis is that weight gain will cease, or even reverse.
Timepoint [2] 1738 0
Over a period of twelve weeks.
Secondary outcome [3] 1739 0
Assess neuropsychological change. The hypothesis is that cognition will improve.
Timepoint [3] 1739 0
After 12 weeks.
Secondary outcome [4] 1740 0
Assess libido and sexual performance change. The hypothesis is that libido and performance will improve for those previously taking risperidone or amisulpride, and possibly olanzapine.
Timepoint [4] 1740 0
After 12 weeks.

Eligibility
Key inclusion criteria
Schizophrenic and schizoaffective patients, who for clinical reasons are being switched from another SGA to aripiprazole, will be eligible for the study.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The raters will not know which tapering protocol a patient is on. Clincal reviews will be done by the Principal Investigator who will not do any ratings.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers were provided by a statistician. All even numbers were assigned to one tapering protocol and all odd numbers to the other tapering protocol.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 790 0
Commercial sector/Industry
Name [1] 790 0
Bristol Meyers Squibb Pharmaceuticals
Country [1] 790 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bristol Meyers Squibb Pharmaceuticals
Address
Country
United States of America
Secondary sponsor category [1] 654 0
None
Name [1] 654 0
Nil
Address [1] 654 0
Country [1] 654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2075 0
Sunshine Hospital (MWAMHS)
Ethics committee address [1] 2075 0
Ethics committee country [1] 2075 0
Australia
Date submitted for ethics approval [1] 2075 0
Approval date [1] 2075 0
Ethics approval number [1] 2075 0

Summary
Brief summary
The aims of this project are to:
- Monitor the benefits and risks of slowly reducing the dosage of previous antipsychotic medicine, while taking aripiprazole. We expect that either of the reductions, unlike sudden discontinuation, will prevent a relapse of your illness.
- Assess the side effects and changes in mental state weekly during tapering, and the remainder of the 12 weeks study. We expect that the slower of the two reductions will be accompanied by fewer side effects.
- Assess weight, and other complications of obesity, over a period of 12 weeks. We expect weight gain to cease, or even reverse.
- Assess psychological and other brain functions over 12 weeks. We expect that thinking, remembering, coordination etc., will improve.
- Assess sexual interest and performance over three months. We expect these to improve for patients previously taking medicines known to have these side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35899 0
Address 35899 0
Country 35899 0
Phone 35899 0
Fax 35899 0
Email 35899 0
Contact person for public queries
Name 9835 0
Ms Sally Li
Address 9835 0
Adult Mental Health Rehabilitation Unit (AMHRU)
Sunshine Hospital
176 Furlong Road
St Albans VIC 3021
Country 9835 0
Australia
Phone 9835 0
+61 3 93643792
Fax 9835 0
+61 3 83451900
Email 9835 0
Sally.Li@wh.org.au
Contact person for scientific queries
Name 763 0
Associate Professor Norman Moore
Address 763 0
Adult Mental Health Rehabilitation Unit (AMHRU)
Sunshine Hospital
176 Furlong Road
St Albans VIC 3021
Country 763 0
Australia
Phone 763 0
+61 3 83451791
Fax 763 0
+61 3 83451900
Email 763 0
Norman.Moore@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.