Antipsychotic-induced weight gain (AiWG)
Conditions
Interventions
Trade Name: Metformine HCL Mylan
Product Name: Metformine HCL
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Ora
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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 a diagnosis of bipolar disorder according to DSM-IV-TR or DSM-5 criteria. 3. Have been using an antipsychotic for at least 3 months (as most AiWG occurs in the first weeks to months of treatment; the participant may have switched antipsychotic use in the past 3 months); 4. Are willing to undergo lifestyletherapy; 5. Speak and read Dutch; 6. Are found mentally competent by their treating physician; 7. Are at least 16 years of age; 8. 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
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 2 reported consumptions daily and a gGT of over 60U/L or a CDT >2.2% (measured in blood using the N-Latex CDT method). 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. Suffer from diabetes mellitus; 6. Are pregnant or breast feed or women of child bearing age using no contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To optimize the application of an existing drug, metformin, for a new indication, AiWG, by showing that metformin in combination with lifestyle interventions reduces AiWG compared to placebo in combination with lifestyle interventions. ;Secondary Objective: Furthermore, we aim to investigate the difference in reduction of AiWG between subgroups; clozapine use versus other antipsychotic use and patients with schizophrenia and bipolar disorder. Additionally, we aim to examine the difference in metformin-induced weight reduction between participants on high-risk agents -risperidone, olanzapine, clozapine and quetiapine- vs. all other antipsychotics and between self-reported weight gain due to antipsychotic use vs weight gain due to other reasons. At last, we aim to assess whether metformin compared to placebo improves metabolic traits, quality of life, general physical and psychological health, cost effectiveness and whether genetic liability to BMI and metabolic syndrome may help estimate weight reduction following initiation of metformin treatment.;Primary end point(s): The primary outcome measure is difference in weight (from treatment inception until 26 weeks of treatment) as a continuous trait.;Timepoint(s) of evaluation of this end point: Timepoints of evaluation: Week 0 (Visit 1) Week 13 (Visit 3) Week 26 (Visit 4) Week 52 (Visit 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We aim to investigate the difference in reduction of AiWG between subgroups; clozapine use versus other antipsychotic use and between patients with schizophrenia and bipolar disorder. Additionally, we aim to examine the difference in metformin-induced weight reduction between participants on high-risk agents -risperidone, olanzapine, clozapine and quetiapine- vs. all other antipsychotics and between self-reported weight gain due to antipsychotic use vs weight gain due to other reasons. ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation: Week 0 (Visit 1) Week 13 (Visit 3) Week 26 (Visit 4) Week 52 (Visit 5) | — |
Countries
Netherlands
Contacts
Public ContactJurjen Luykx
UMC Utrecht
Outcome results
None listed