Weight Gain Clinical Trial
Official title:
A Prospective/Parallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia
and moderate to severe manic episode.
Olanzapine is among the many antipsychotic agents associated with weight gain . The
mechanism for antipsychotic drug-related weight gain is not known, although antagonism of
serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized.
The purpose of this study is to observe the efficacy of a psychoeducational programme in
managing the increased weight as a side effect of the olanzapine treatment.
Interventions to prevent weight gain associated with olanzapine should at least include
periodic monitoring and recommendations for changes in diet and physical activity.
This is a phase IV, randomised, parallel study of subjects previously treated with
olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the
beginning of antipsychotic treatment (assessed during the routine visits). For the first 12
weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one
year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine +
psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all
patients undergo the psychoeducational programme. The efficacy of this programme will be
assessed monitoring the mean difference from baseline to endpoint in total body weight and
BMI.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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