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Completed

NCT Number: NCT01593774

Melatonin for Prevention of Metabolic Side Effects of Olanzapine

The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.

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Key information

Conditions

Schizophrenia Body Weight Body Weight Changes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperlipidemias Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Gain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shafa Psychiatric Hospital

Rasht, Gilan Province, 55599-41939, Iran

About this study

Atypical antipsychotics including olanzapine are associated with significant metabolic side effects. Animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65 year
  • First episode schizophrenia (DSM-IV-TR)
  • Ability to take medicine orally
  • Eligible for starting olanzapine

Exclusion criteria

  • Married women who are at reproductive age
  • History of taking olanzapine in the recent 3 months
  • History of allergy or intolerance to olanzapine
  • History of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels)
  • Liver, kidney, cerebrovascular or cardiovascular disease
  • Diabetes, metabolic syndrome
  • Cancer
  • Using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs
  • Using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil)
  • Delirium
  • Need for administration of other antipsychotics
  • Substance abuse

Treatment and study plan

Melatonin

Drug

Tablet melatonin 3 mg/day at 9 pm as intervention group

Placebo

Drug

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Primary outcomes

  1. Change from baseline in weight at week eight

    Time frame: Baseline and week eight

Secondary outcomes

  1. Change from baseline in Triglyceride at week 4

    Time frame: Baseline and week 4

  2. Change from baseline in HDL at week 4

    Time frame: Baseline and week 4

  3. Change from baseline in LDL at week 4

    Time frame: Baseline and week 4

  4. Change from baseline in Total Cholesterol at week 4

    Time frame: Baseline and Week 4

  5. Change from baseline in weight at week 4

    Time frame: Baseline and week 4

  6. Change from baseline in Fasting blood sugar at week 4

    Time frame: Baseline and week 4

  7. Change from baseline in blood pressure at week 4

    Time frame: Baseline and week 4

  8. Change from baseline in body mass index (BMI) at week 4

    Time frame: Baseline and week 4

  9. Change from baseline in waist to hip ratio at week 4

    Time frame: Baseline and week 4

  10. Change from baseline in Positive and negative syndrome scale (PANSS) at week 4

    Time frame: Baseline and week 4

  11. Change from baseline in Positive and negative syndrome scale (PANSS) at week 8

    Time frame: Baseline and week 8

  12. Change from baseline in Triglyceride at week 48

    Time frame: Baseline and week 8

  13. Change from baseline in HDL at week 8

    Time frame: Baseline and week 8

  14. Change from baseline in LDL at week 8

    Time frame: Baseline and week 8

  15. Change from baseline in Total Cholesterol at week 8

    Time frame: Baseline and Week 8

  16. Change from baseline in Fasting blood sugar at week 8

    Time frame: Baseline and week 8

  17. Change from baseline in blood pressure at week 8

    Time frame: Baseline and week 8

  18. Change from baseline in body mass index (BMI) at week 8

    Time frame: Baseline and week 8

  19. Change from baseline in waist to hip ratio at week 8

    Time frame: Baseline and week 8

  20. Change from baseline in Insulin at week 8

    Time frame: Baseline and week 8

  21. Number of adverse events at the end of the study in each group

    Time frame: Baseline, week 4, and 8

  22. Changes from baseline in HOMA-IR values at week 8

    Time frame: Baseline and week 8

Sponsors and collaborators

Lead sponsor

Guilan University of Medical Sciences

Other

Registry information

Official study title

Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Apr 9, 2013

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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