Status:
COMPLETED
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
Lead Sponsor:
Bjorn H. Ebdrup
Conditions:
Obesity
Metabolic Syndrome X
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. The inve...
Detailed Description
The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®). Secondary endpoints comprise both physiological/metabolic parameters and cognitive measu...
Eligibility Criteria
Inclusion
- Age: 18 - 65 years
- Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included
- Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment)
- BMI ≥30 kg/m2
- HbA1c \< 6,5 %
Exclusion
- Substance dependence (ICD-10: F1x.2 (apart from nicotine addiction F17.2))
- Diabetes or HbA1c ≥6.5%
- Contraindications to MRI (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the MRI scanner))
- Previous head trauma with a loss of consciousness for more than 5 minutes
- Pregnancy (screened by urine human chorionic gonadotropin (hCG),lactation or no acceptance to use effective contraception during the intervention period
- Severe somatic disease, including inflammatory bowel disease and chronic ketoacidosis
- Allergy to exenatide
- Coercive measures according the Danish Law of Psychiatry
- conditions that according to sponsor are not congruous with participation in the study
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01794429
Start Date
February 1 2013
End Date
June 1 2015
Last Update
June 24 2015
Active Locations (1)
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1
Cnsr/Cins
Glostrup Municipality, Denmark, 2600