RecruitingPhase 4ACTRN12605000516684

Switching to aripiprazole from other second-generation antipsychotics.

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

Sponsor

Bristol Meyers Squibb Pharmaceuticals

Enrollment

40 participants

Start Date

Apr 6, 2006

Study Type

Interventional

Conditions

Schizophrenic and schizoaffective disorder

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.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is following patients with schizophrenia or schizoaffective disorder who are switching from one antipsychotic medication to a newer one called aripiprazole. The switch is happening because of clinical reasons (such as side effects from the previous medication). Researchers want to monitor how the changeover affects patients' symptoms, side effects, weight, cognitive (thinking) abilities, and sexual function over 12 weeks. The goal is to find the safest way to make this kind of medication switch. You may be eligible if: - You have been diagnosed with schizophrenia or schizoaffective disorder - Your doctor has decided, for clinical reasons, to switch you from your current antipsychotic medication to aripiprazole You may NOT be eligible if: - There are no specific exclusion criteria listed for this study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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).

Locations(1)

Australia

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ACTRN12605000516684