None listed
Conditions
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.
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 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 SG
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).
Sponsors
Bristol Meyers Squibb Pharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Schizophrenic and schizoaffective patients, who for clinical reasons are being switched from another SGA to aripiprazole, will be eligible for the study.
Exclusion criteria
No exclusion criteria
Outcome results
None listed