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

Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study - Treatment of antipsychotic associated obesity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005404-17-DK

Enrollment

Registered

2013-01-02

Start date

2013-01-16

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Trade Name: Bydureon Pharmaceutical Form: Solution for injection in pre-filled syringe Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the p

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 1 month 3 moths	—

Measure

Time frame

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 1 month 3 moths

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Secondary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

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. ;Timepoint(s) of evaluation of this end point: 3 months

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Countries

Denmark

Contacts

Public ContactPsychiatric Center Glostrup

Center for Neuropsychiatric Schizophrenia Research

bebdrup@cnsr.dk00452613 3832

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026