Schizophrenia
Conditions
Keywords
Schizophrenia, weight management programme
Brief summary
The study is a prospective, randomized, open-label study.
Detailed description
The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.
Interventions
BEHAVIORALweight management program
12 sessions, psychoeducation
Sponsors
Eli Lilly and Company
Else Kröner-Fresenius-Centre for Nutritional Medicine
Technical University of Munich
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia * Ages between 18 and 65 * Informed consent * Weight gain of at least 1.5 kg in the first 4 weeks * A sufficient understanding to participate adequately in the weight management program * Patients must agree to cooperate with all tests and examinations required by the protocol. * Each patient must understand the nature of the study and must sign an informed consent document.
Exclusion criteria
* Serious, unstable somatic illnesses * Illnesses associated with weight gain including renal and endocrine diseases * Weight change greater than 3 kg in the preceding three months * Weight gain less than 1.5 kg in the first 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference in mean weight gain | November 2007 |
Secondary
| Measure | Time frame |
|---|---|
| changes in waist circumference, blood pressure, blood lipids, fasting glucose | November 2007 |
Countries
Germany
Outcome results
None listed