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Completed

NCT Number: NCT05663749

Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics

Metabolic syndrome is common in patients of schizophrenia. It can add to morbidity, loss of functionality and discontinuation of antipsychotic medication. Apart from metformin, there are limited treatment options as add on-s to antipsychotics for treatment of metabolic syndrome. There have been placebo-controlled studies of Topiramate as an adjuvant but the present study would be the first head-on trial between these drugs for treatment of metabolic syndrome in patients of schizophrenia.

If the outcome measures show a significant improvement with add on topiramate when compared with Metformin, then add on Topiramate can be a preferred treatment for metabolic syndrome in patients with schizophrenia on atypical antipsychotics. The adverse effects of Metformin can be side-stepped and Topiramate can also be given in conditions which are contraindications for Metformin. Thus, Topiramate can be a good alternative to metformin especially in conditions like liver, cardiac and renal impairment where metformin use should be avoided. Topiramate can not only improve metabolic parameters but can also have a beneficial effect on the symptom severity of schizophrenia. Thus, it can be a good augmentation drug to be used along with antipsychotics in these patients.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept of Psychiatry, Aiims, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

Study Design: The proposed study will be a randomised, parallel arm, active controlled, open label, clinical trial.

Study Setting: The proposed study will be conducted at the out-patient (OP) and the in-patient (IP) settings of the Department of Psychiatry, All India Institute of Medical Sciences, Bhubaneswar.

Study Groups: The study population will comprise of 60 patients with schizophrenia (F20 according to ICD 10 DCR) on atypical antipsychotics for more than 3 months diagnosed with metabolic syndrome.

Sample size: Sample size calculation has been done based on the expected difference in the cardiovascular risk scoring (QRISK3), the primary outcome measure of our study. Sample size of 23 per group will achieve a power of 80%, to detect the difference of 5% in cardiovascular risk scoring (QRISK3) between the groups with standard deviation as 6.0 and a level of significance 0.05. Assuming an attrition rate of 25%, 30 patients will be recruited per group.

Details of Control(s): It is an active controlled study where the control group will receive add-on metformin along with the ongoing atypical antipsychotic.

Details of intervention:

The patients who are randomized to Topiramate group will be receiving Topiramate at a stable dose of 50 mg/day during the study period that is for 8 weeks along with the ongoing atypical antipsychotic.

The patients who are randomized to Metformin group will be receiving Metformin at dose of 500 mg/day twice a day, a total of 1000 mg/day for 8 weeks along with the ongoing atypical antipsychotic.

Duration of study: The study will be conducted for a period of 18 months

Investigation specifically related to Protocols:

The following Psychiatric scales will be used:

  • PANSS: The Positive and Negative Syndrome Scale
  • CGI-SCH Scales: The Clinical Global Impression-Schizophrenia scale (for Severity and Improvement) The following investigations will be done for cardio-metabolic profile;

a) QRISK3 b) Lipid profile c)Fasting serum insulin by ELISA for insulin resistance (HOMA-IR) d)Fasting blood glucose for insulin resistance (HOMA-IR)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients clinically diagnosed with schizophrenia (F20 according to ICD-10 DCR) on a stable dose of atypical antipsychotic for more than 3 months.
  • Patients with metabolic syndrome (as per NCEP ATP III Definition).
  • Patients above 25 years of age of either gender.
  • Legally authorized representative (LAR) giving voluntary written consent for participation in the study.

Exclusion criteria

  • Patients on combination of antipsychotics.
  • Patients having any contraindication for Metformin/Topiramate.
  • History of any psychoactive substance use in harmful use or dependence pattern except tobacco.
  • Any co-morbid medical, psychiatric or neurological disorders like hypertension, coronary artery disease, hypothyroidism, arthritis.
  • History of any significant head injury or organic diseases.
  • Pregnant and breastfeeding females.

Treatment and study plan

metformin

Drug

1000mg for 8 weeks

Other names: Dibeta SR, Metgen, Glycomet

Topiramate

Drug

50mg for 8 weeks

Other names: Topamax, Topirol, Topaz

Primary outcomes

  1. Change in the QRISK3 score.

    Time frame: 8 weeks

    QRISK3 (QRESEARCH cardiovascular risk algorithm)2018 algorithm- used for calculating the cardiovascular risk in the upcoming 10 years. It is measured for the age group of 25 to 84 years using information like age, weight, height, BMI, Lipid profile, past history of CKD, angina, migraine etc. Higher score indicates higher risk.

Secondary outcomes

  1. Change in the LDL/HDL ratio(Low density lipoprotein/High density lipoprotein).Higher ratio indicates higher risk

    Time frame: 8 weeks

    Calculated from the lipid profile

  2. Change in Insulin Resistance (HOMA-IR)(homeostasis model assessment-estimated insulin resistance ).

    Time frame: 8 weeks

    Calculated from serum insulin level and fasting glucose level according to the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  3. Change in Positive and negative syndrome scale

    Time frame: 8 weeks

    Positive and negative syndrome scale, a scale used to measure the symptom severity in patients of schizophrenia including positive, negative and general psychopathology.Higher scores indicate more severity of illness.Maximum score 30 and maximum 210

  4. Change in Clinical Global Impression-Schizophrenia scale

    Time frame: 8 weeks

    Scale that is used to measure the baseline severity, change in severity of illness with treatment and global improvement. More score indicates more impairment.

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Efficacy and Safety of Add-on Topiramate vs Metformin on Cardio-Metabolic Profile in Patients With Schizophrenia on Atypical Antipsychotics With Metabolic Syndrome: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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