Melatonin for Prevention of Metabolic Side Effects of Olanzapine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad Jafar Modabbernia, Guilan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01593774
First received: May 6, 2012
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Melatonin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.

Resource links provided by NLM:


Further study details as provided by Guilan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline in weight at week eight [ Time Frame: Baseline and week eight ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Triglyceride at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in HDL at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in LDL at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Total Cholesterol at week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in weight at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Fasting blood sugar at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in body mass index (BMI) at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in waist to hip ratio at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Positive and negative syndrome scale (PANSS) at week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Positive and negative syndrome scale (PANSS) at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Triglyceride at week 48 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in HDL at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in LDL at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Total Cholesterol at week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Fasting blood sugar at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in body mass index (BMI) at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in waist to hip ratio at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in Insulin at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • Number of adverse events at the end of the study in each group [ Time Frame: Baseline, week 4, and 8 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in HOMA-IR values at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week
Drug: Melatonin
Tablet melatonin 3 mg/day at 9 pm as intervention group
Placebo Comparator: Placebo
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
Drug: Placebo
Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593774

Locations
Iran, Islamic Republic of
Shafa Psychiatric Hospital
Rasht, Guilan, Iran, Islamic Republic of, 55599-41939
Sponsors and Collaborators
Guilan University of Medical Sciences
Investigators
Study Chair: Mohammad Jafar Modabbernia, MD Guilan University of Medical Sciences
  More Information

Publications:
Responsible Party: Mohammad Jafar Modabbernia, Associate Professor of Psychiatry, Guilan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01593774     History of Changes
Other Study ID Numbers: GUMS-9277
Study First Received: May 6, 2012
Last Updated: April 8, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Guilan University of Medical Sciences:
Melatonin
Olanzapine
Metabolic side effects
Psychosis
Hyperlipidemia
Hyperglycemia
Weight gain
Diabetes

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Melatonin
Olanzapine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014