Antipsychotic medication and weight gain v1
Research type
Research Study
Full title
ENTER: Effects of Neuromodulation and cognitive training on eating responses.
IRAS ID
251809
Contact name
Ulrike Schmidt
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN13280178
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
Weight gain is an established side effect of antipsychotic medication affecting 15-72% of individuals with schizophrenia. Behavioural interventions have limited effectiveness in acutely unwell patients who have few opportunities for exercise during an inpatient stay. Therefore, there is a need for development of new treatments.
This study aims to investigate the feasibility of combining Approach Bias Modification (ABM) training and Transcranial Direct Current Stimulation (tDCS) to reduce food cravings in people who take antipsychotic medication. The ABM training is a computerised training that seeks to alter responses towards food that people are not consciously aware of. It involves a simple training of arm movements in front of a computer screen. TDCS is a non-invasive form of brain stimulation. It stimulates specific brain areas using a mild electrical current (2 mA) via small electrodes placed on the scalp. ABM and tDCS will be delivered at the same time, i.e. participants will engage in ABM training whilst receiving tDCS.
Male and female service users (aged 18-65) will be eligible if they have a DSM-V diagnosis of schizophrenia or schizoaffective disorder, and have been on a stable dose of antipsychotic medication for at least 6 weeks prior to study enrolment.
The study will be conducted at King’s College London and at inpatient, outpatient and community services at the South London and Maudsley NHS Foundation Trust (SLaM).
All participants will receive 5 sessions of combined ABM and real or sham tDCS over 3-4 weeks. Food craving and other outcomes will be measured in all participants at the start of the study,
end of the study, and at the 2-week follow-up.The project has been registered on the Clinical Trials database (No: ISRCTN13280178). The project is funded by the SLaM /IoPPN Biomedical Research Centre and it will end on the 6th May 2020.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0279
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion