Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue (TAO)

B

Bjorn H. Ebdrup

Status and phase

Completed
Phase 3

Conditions

Schizophrenia
Obesity
Drug-induced Obesity
Metabolic Syndrome X

Treatments

Drug: Placebo
Drug: Exenatide

Study type

Interventional

Funder types

Other

Identifiers

NCT01794429
EudraCT nr: 2012-005404-17

Details and patient eligibility

About

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).

Full 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 measurements: Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate. Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide. The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. Functional MRI will provide this data and the images will be correlated to both cognitive tests and questionnaires. Cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in subjective quality of life (questionnaires).

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Subcutaneum injection of placebo once-weekly for 3 months
Treatment:
Drug: Placebo
exenatide
Active Comparator group
Description:
Subcutaneum injection of exenatide once-weekly for 3 months
Treatment:
Drug: Exenatide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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