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The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial

The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial
The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial
Aim
To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis.

Materials and Methods
A double‐blind, randomized, placebo‐controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first‐episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once‐daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale.

Results
Seven hundred and ninety‐nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study‐specific medication and protocol (n = 50). Forty‐seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference −6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group.

Conclusions
This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.
feasibility, liraglutide, obesity, overweight, pilot, schizophrenia, severe mental illness
1462-8902
1262-1271
Whicher, Clare A.
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Price, Hermione C.
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Phiri, Peter
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Rathod, Shanaya
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Barnard-Kelly, Katharine
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Kandala, Ngianga ii I
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Thorne, Kerensa
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Asher, Carolyn
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Peveler, Robert
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McCarthy, Joanne
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Holt, Richard
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Whicher, Clare A.
95b0c7fa-2466-4de4-a19f-a81c1cd1d6eb
Price, Hermione C.
0390ec6b-4a7e-41c2-bd93-6aee784c2213
Phiri, Peter
02de1b5c-df46-4231-8f81-a0e3e3e95ce7
Rathod, Shanaya
b4dddbe5-e4aa-4069-bd03-20cd6332639c
Barnard-Kelly, Katharine
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Kandala, Ngianga ii I
07a8c745-6e54-4496-8e8e-bbc74d990886
Thorne, Kerensa
21a60886-12d9-4ace-b9cd-cf0f64aca53d
Asher, Carolyn
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Peveler, Robert
93198224-78d9-4c1f-9c07-fdecfa69cf96
McCarthy, Joanne
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Holt, Richard
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Whicher, Clare A., Price, Hermione C., Phiri, Peter, Rathod, Shanaya, Barnard-Kelly, Katharine, Kandala, Ngianga ii I, Thorne, Kerensa, Asher, Carolyn, Peveler, Robert, McCarthy, Joanne and Holt, Richard (2021) The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial. Diabetes, Obesity and Metabolism, 23 (6), 1262-1271. (doi:10.1111/dom.14334).

Record type: Article

Abstract

Aim
To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis.

Materials and Methods
A double‐blind, randomized, placebo‐controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first‐episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once‐daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale.

Results
Seven hundred and ninety‐nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study‐specific medication and protocol (n = 50). Forty‐seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference −6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group.

Conclusions
This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.

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Accepted/In Press date: 28 January 2021
e-pub ahead of print date: 2 February 2021
Published date: June 2021
Additional Information: Publisher Copyright: © 2021 John Wiley & Sons Ltd
Keywords: feasibility, liraglutide, obesity, overweight, pilot, schizophrenia, severe mental illness

Identifiers

Local EPrints ID: 446726
URI: http://eprints.soton.ac.uk/id/eprint/446726
ISSN: 1462-8902
PURE UUID: d0768a81-e2d6-4c4b-9f68-2a0465126986
ORCID for Robert Peveler: ORCID iD orcid.org/0000-0001-5596-9394
ORCID for Richard Holt: ORCID iD orcid.org/0000-0001-8911-6744

Catalogue record

Date deposited: 19 Feb 2021 17:31
Last modified: 17 Mar 2024 06:18

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Contributors

Author: Clare A. Whicher
Author: Hermione C. Price
Author: Peter Phiri
Author: Shanaya Rathod
Author: Katharine Barnard-Kelly
Author: Ngianga ii I Kandala
Author: Kerensa Thorne
Author: Carolyn Asher
Author: Robert Peveler ORCID iD
Author: Joanne McCarthy
Author: Richard Holt ORCID iD

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