Optimizing the use of metformin in the management of weight gain caused by the use of antipsychotic medication.

Phase 1

• Conditions: Antipsychotic-induced weight gain (AiWG); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-000053-27-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1.Have a diagnosis of schizophrenia spectrum disorders according to DSM-IV-TR or DSM-5 criteria as summarized in DSM-5 chapter Schizophrenia Spectrum and other Psychotic Disorders, with the exception of substance/medication-induced psychotic disorder, psychotic disorder due to another medical condition, catatonia associated with another mental disorder, catatonic disorder due to another medical condition, and unspecified catatonia. Thus, included may be participants with a delusional disorder, schizotypal personality disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder, other specified schizophrenia spectrum and other psychotic disorder, and unspecified schizophrenia and other psychotic disorder;
2.Have been using the an antipsychotic for at least 3 months (as most AiWG occurs in the first weeks to months of treatment);
3.Are willing to undergo lifestyle interventions;
4.Speak and read Dutch;
5.Are found mentally competent by their treating physician;
6.Are at least 16 years of age;
7.Are overweight (BMI>25);

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Suffer from neurodegenerative extrapyramidal disease;
2.Carry metformin-related contra-indications, i.e.: conditions predisposing to tissue hypoxia (such as congestive heart failure, recent myocardial infarction and respiratory failure), metabolic acidosis, precoma diabeticum, kidney failure (GFR<30ml/min) and conditions predisposing to kidney failure (e.g. dehydration, infections and hypovolemic shock), disorders in the use of alcohol defined as > 2 reported consumptions daily and/or a gGT of over 60U/L, and liver failure. Should any of the lab values (CRP, GFR, triglycerides, LDL and HDL levels, HbA1c, glucose and insulin in blood) be above or below the normal range, we will contact the participant’s G.P. and schedule an appointment if needed. Should the participant’s glucose level and/ or HbA1c give rise to a suspicion of diabetes mellitus (finger prick glucose >11,0 mmol/l), the G.P. will indicate whether metformin may be prescribed or an alternate agent. In the event metformin is indicated according to the G.P., the patient will drop out;
3.Use of one or more of the following medication(s):
-NSAIDs
-ACE-inhibitors
-ARBs (angiotensin receptor blockers)
-diuretics
-OCT (organic cation transporters) -1 and 2 inhibitors (e.g. cimetidine, dolutegravir, isavuconazol, trimethoprim, vandetanib, crizotinibib, vandetanib, and verapamil) and inductors (e.g. rifampicin);
4.Suffer from vitamin B12 deficiency;
5.Are pregnant or breast feed.
6. Suffer from diabetes mellitus.

Study & Design

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