Clozapine Induced Weight Gain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03996356|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment|
|Weight Gain Antipsychotic Agents Pharmacogenetics||Other: No study intervention - observational study|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Clozapine Induced Weight Gain: A Pharmacogenetic Study|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||October 2021|
- Other: No study intervention - observational study
This is an observational study where the comparative groups will be determined by the genetic variants (SNPs) of subjects and not an intervention, per se.
- Body-mass index (BMI) [ Time Frame: 12 months ]BMI will be calculated by weight (kg)/ height^2 (m^2).
- Leptin gene promoter region single nucleotide polymorphisms (SNPs) (rs7799039) [ Time Frame: 12 months ]SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-2548G or c.-2548A) .
- Serotonin 5-HT 2C receptor gene single nucleotide polymorphisms (SNPs) (rs3813929) [ Time Frame: 12 months ]SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-759C or c.-759T) .
- Blood haemoglobin A1c concentration [ Time Frame: 6 months ]Haemoglobin A1c concentrations will be determined by ion-exchange HPLC (G8, Tosoh, Amsterdam, Netherlands)
- Waist:hip ratio [ Time Frame: 12 months ]Waist:hip ratio will be calculated by waist circumference (cm)/hips circumference (cm)
- Lipid profile [ Time Frame: 12 months ]Serum lipid profiles will include total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride. These will be measured by enzymatic colorimetric methods on cobas-Roche analysers (Roche, Burges Hill, UK) except LDL cholesterol, which will be calculated using the Friedewald equation ([LDL cholesterol] = [Total cholesterol] - ([Triglyceride] / 2.2) - [HDL cholesterol]
- Clozapine side effects assessment by Clinical Global Impression (CGI) scale [ Time Frame: 12 months ]Clinical Global Impression (CGI) scale is a validated tool to assess clozapine side effects (Ref: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville,MD, U.S. Department of Health, Education, and Welfare)
- Clozapine:nor clozapine ratio [ Time Frame: 12 months ]Clozapine:nor clozapine ratio is calculated by clozapine (ug/L)/ nor clozapine (ug/L) both measured by high-performance liquid chromatography with diode-array detection.
Biospecimen Retention: Samples With DNA
4 blood samples to be taken at 0 and 6 months (2x EDTA plasma/whole blood, 2x serum).
Biochemical markers and status of 2 common single nucleotide polymorphisms will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996356
|Contact: Brian P Tennant, PhD||(+44)firstname.lastname@example.org|
|Contact: Rhian Beynon, MScemail@example.com|
|Principal Investigator:||Brian P Tennant, PhD||Cwm Taf Morgannwg UHB|