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Weight GainNCT03996356

Clozapine Induced Weight Gain

An observational study of Weight Gain and Antipsychotic Agents, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
No study intervention - observational study
How many people
160 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2020to Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients on clozapine treatment

Who may be able to join

  • Age 18 years or over
  • Taking/compliant with clozapine antipsychotic medications.
  • Patients meeting the ICD-10 criteria for a diagnosis of schizophrenia, schizoaffective or borderline personality disorders.

Who cannot join

  • History of current alcohol/illicit substance dependency.
  • Unable/ unsuitable to complete the study protocol e.g. acutely ill, suicidal or aggressive patients.
  • Unable to consent to the study.

Trial locations and contacts

1 site in 1 country.

Brian P Tennant, PhD contact

(+44)1685728278

brian.tennant@wales.nhs.uk

Rhian Beynon, MSc contact

01443444500

rhian.beynon@wales.nhs.uk

United Kingdom1 site

  • Cwm Taf University Health Board

    Merthyr Tydfil, Wales, CF47 9DT

    Brian P Tennant, PhD, (44)1685728278, brian.tennant@wales.nhs.uk

    Rhian Beynon, MSc, 01443444500, rhian.beynon@wales.nhs.uk

Other trials in United Kingdom

About this study

Official title: Clozapine Induced Weight Gain: A Pharmacogenetic Study

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.

Being tested
No study intervention - observational study
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No study intervention - observational studyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body-mass index (BMI)

    BMI will be calculated by weight (kg)/ height^2 (m^2).

    Measured: 12 months

  2. Leptin gene promoter region single nucleotide polymorphisms (SNPs) (rs7799039)

    SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-2548G or c.-2548A) .

    Measured: 12 months

  3. Serotonin 5-HT 2C receptor gene single nucleotide polymorphisms (SNPs) (rs3813929)

    SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-759C or c.-759T) .

    Measured: 12 months

Secondary outcomes (5)

  1. Blood haemoglobin A1c concentration

    Haemoglobin A1c concentrations will be determined by ion-exchange HPLC (G8, Tosoh, Amsterdam, Netherlands)

    Measured: 6 months

  2. Waist:hip ratio

    Waist:hip ratio will be calculated by waist circumference (cm)/hips circumference (cm)

    Measured: 12 months

  3. Lipid profile

    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]

    Measured: 12 months

  4. Clozapine side effects assessment by Clinical Global Impression (CGI) scale

    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)

    Measured: 12 months

  5. Clozapine:nor clozapine ratio

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2019
  2. Study startMar 2020 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996356
Sponsor's protocol ID
CT/688/000000/16
Status last verified
Jun 2019
First submitted
20 Jun 2019
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, Weiden PJ. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999 Nov;156(11):1686-96. doi: 10.1176/ajp.156.11.1686.

    PubMed 10553730

  • Baptista T, Kin NM, Beaulieu S, de Baptista EA. Obesity and related metabolic abnormalities during antipsychotic drug administration: mechanisms, management and research perspectives. Pharmacopsychiatry. 2002 Nov;35(6):205-19. doi: 10.1055/s-2002-36391.

    PubMed 12518268

  • Basile VS, Masellis M, McIntyre RS, Meltzer HY, Lieberman JA, Kennedy JL. Genetic dissection of atypical antipsychotic-induced weight gain: novel preliminary data on the pharmacogenetic puzzle. J Clin Psychiatry. 2001;62 Suppl 23:45-66.

    PubMed 11603885

  • Couchman L, Morgan PE, Spencer EP, Flanagan RJ. Plasma clozapine, norclozapine, and the clozapine:norclozapine ratio in relation to prescribed dose and other factors: data from a therapeutic drug monitoring service, 1993-2007. Ther Drug Monit. 2010 Aug;32(4):438-47. doi: 10.1097/FTD.0b013e3181dad1fb.

    PubMed 20463634

  • Mammes O, Betoulle D, Aubert R, Herbeth B, Siest G, Fumeron F. Association of the G-2548A polymorphism in the 5' region of the LEP gene with overweight. Ann Hum Genet. 2000 Sep;64(Pt 5):391-4. doi: 10.1017/s0003480000008277.

    PubMed 11281277

  • Mantzoros CS. The role of leptin in human obesity and disease: a review of current evidence. Ann Intern Med. 1999 Apr 20;130(8):671-80. doi: 10.7326/0003-4819-130-8-199904200-00014.

    PubMed 10215564

  • Ohlson LO, Larsson B, Svardsudd K, Welin L, Eriksson H, Wilhelmsen L, Bjorntorp P, Tibblin G. The influence of body fat distribution on the incidence of diabetes mellitus. 13.5 years of follow-up of the participants in the study of men born in 1913. Diabetes. 1985 Oct;34(10):1055-8. doi: 10.2337/diab.34.10.1055.

    PubMed 4043554

  • Reynolds GP, Zhang ZJ, Zhang XB. Association of antipsychotic drug-induced weight gain with a 5-HT2C receptor gene polymorphism. Lancet. 2002 Jun 15;359(9323):2086-7. doi: 10.1016/S0140-6736(02)08913-4.

    PubMed 12086765

  • Reynolds GP, Zhang Z, Zhang X. Polymorphism of the promoter region of the serotonin 5-HT(2C) receptor gene and clozapine-induced weight gain. Am J Psychiatry. 2003 Apr;160(4):677-9. doi: 10.1176/appi.ajp.160.4.677.

    PubMed 12668355

Questions about this trial

What is this clinical trial studying?

An observational study of Weight Gain and Antipsychotic Agents, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brian P Tennant, PhD ((+44)1685728278, brian.tennant@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body-mass index (BMI) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996356, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.

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