Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bjorn H. Ebdrup
• Treatments: Antipsychotic Agents; Exenatide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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