Treatment of antipsychotic associated obesity with an antidiabetic agent: the TAO study

Phase 1

• Conditions: Obesity; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-005404-17-DK
• Lead Sponsor: Center for Neuropsychiatric Schizophrenia Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-02
• Study Completion: 2015-07-13
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Age: 18 - 65 years
Diagnosis in the schizophrenic spectrum (ICD-10: F20.x, F25.x)
Treatment with a least one antipsyhcotic agent (FGS/SGA) for a least 3 months
BMI = 30 kg/m2
HbA1c < 6,5 %
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active abuse of psychoactive drugs (ICD-10: F1x.2 (not nicotine))
Contradictions to MRI (metalimplant, pacemaker, claustrofobia, =150 kg (max. weight in the MR scanner))
Former headtrauma with loss of conciousness more than 5 minutes
Pregnancy
Severe medical condition/illness
Allergi towards exenatide (Bydureon®)
Suicidality
Forensic psychiatry patient
Conditions, who according to Sponsor or Invesigator are not fit for joining the investigation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum;Secondary Objective: Moreover we will investigate the associations between GLP-1-analogue treatment and peripheral metabolic parameters as well as associations with central psychological parameters such as magnetic resonance imaging (MRI) scans of the brain and cognitive tests.;Primary end point(s): The primary endpoint is weightloss after 3 moths treatment with the GLP-1-analogue, exenatide.;Timepoint(s) of evaluation of this end point: 1 week<br>1 month<br>3 moths<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The effect of GLP-1-analogue treatment on a wide range of secondary endpoints will be examined. By means of MRI, potential neuroprotective effects and changes in cerebral blood flow will be explored. Changes in cerebral blood flow following GLP-1 analogue treatment, with particular focus on the blood flow in hypothalamus and prefrontal cortex, will be correlated to measures of global cognitive ability. Moreover, associations between GLP-1 analogue treatment, weight loss and improvement in secondary metabolic parameters will be associated with improvements in the patients' subjective quality of life. Finally, we will examine if possible GLP-1 analogue-induced volumetric changes in the striatum are correlated with reductions in the extrapyramidal side effects of antipsychotic medication.<br>;Timepoint(s) of evaluation of this end point: 3 months<br>