SchizophreniaPhase 2NCT01593774
Melatonin for Prevention of Metabolic Side Effects of Olanzapine
A Phase 2 study testing Melatonin in people with Schizophrenia, run by Guilan University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 year
- First episode schizophrenia (DSM-IV-TR)
- Ability to take medicine orally
- Eligible for starting olanzapine
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Hyperlipidemias, Hyperglycemia, Weight Gain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Tablet melatonin 3 mg/day at 9 pm as intervention group
PlaceboDrug
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Placebo (with the same shape and taste as melatonin) at 9 pm as control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight at week eight
Measured: Baseline and week eight
Secondary outcomes (22)
Change from baseline in Triglyceride at week 4
Measured: Baseline and week 4
Change from baseline in HDL at week 4
Measured: Baseline and week 4
Change from baseline in LDL at week 4
Measured: Baseline and week 4
Change from baseline in Total Cholesterol at week 4
Measured: Baseline and Week 4
Change from baseline in weight at week 4
Measured: Baseline and week 4
Change from baseline in Fasting blood sugar at week 4
Measured: Baseline and week 4
Change from baseline in blood pressure at week 4
Measured: Baseline and week 4
Change from baseline in body mass index (BMI) at week 4
Measured: Baseline and week 4
Change from baseline in waist to hip ratio at week 4
Measured: Baseline and week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 4
Measured: Baseline and week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 8
Measured: Baseline and week 8
Change from baseline in Triglyceride at week 48
Measured: Baseline and week 8
Change from baseline in HDL at week 8
Measured: Baseline and week 8
Change from baseline in LDL at week 8
Measured: Baseline and week 8
Change from baseline in Total Cholesterol at week 8
Measured: Baseline and Week 8
Change from baseline in Fasting blood sugar at week 8
Measured: Baseline and week 8
Change from baseline in blood pressure at week 8
Measured: Baseline and week 8
Change from baseline in body mass index (BMI) at week 8
Measured: Baseline and week 8
Change from baseline in waist to hip ratio at week 8
Measured: Baseline and week 8
Change from baseline in Insulin at week 8
Measured: Baseline and week 8
Number of adverse events at the end of the study in each group
Measured: Baseline, week 4, and 8
Changes from baseline in HOMA-IR values at week 8
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guilan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Jafar Modabbernia, Guilan University of Medical Sciences
- Investigators
- Mohammad Jafar Modabbernia, MD, Study chair, Guilan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593774
- Sponsor's protocol ID
- GUMS-9277
- Status last verified
- Apr 2013
- First submitted
- 6 May 2012
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raskind MA, Burke BL, Crites NJ, Tapp AM, Rasmussen DD. Olanzapine-induced weight gain and increased visceral adiposity is blocked by melatonin replacement therapy in rats. Neuropsychopharmacology. 2007 Feb;32(2):284-8. doi: 10.1038/sj.npp.1301093. Epub 2006 May 10.
PubMed 16710316Borba CP, Fan X, Copeland PM, Paiva A, Freudenreich O, Henderson DC. Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia. J Clin Psychopharmacol. 2011 Oct;31(5):653-8. doi: 10.1097/JCP.0b013e31822bb573.
PubMed 21869685Anderson G, Maes M. Melatonin: an overlooked factor in schizophrenia and in the inhibition of anti-psychotic side effects. Metab Brain Dis. 2012 Jun;27(2):113-9. doi: 10.1007/s11011-012-9307-9. Epub 2012 Apr 25.
PubMed 22527998Modabbernia A, Heidari P, Soleimani R, Sobhani A, Roshan ZA, Taslimi S, Ashrafi M, Modabbernia MJ. Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study. J Psychiatr Res. 2014 Jun;53:133-40. doi: 10.1016/j.jpsychires.2014.02.013. Epub 2014 Feb 24.
PubMed 24607293
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
- ClinicalTrials.gov ID
- NCT01593774
- Acronym / sponsor ID
- GUMS-9277
- Conditions
- Schizophrenia
- Keywords
- Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Guilan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninTablet melatonin 3 mg/day at 9 pm as intervention group for eight week |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (with the same shape and taste as melatonin) at 9 pm as control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 year
- First episode schizophrenia (DSM-IV-TR)
- Ability to take medicine orally
- Eligible for starting olanzapine
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninTablet melatonin 3 mg/day at 9 pm as intervention group | Drug | Melatonin |
| PlaceboPlacebo (with the same shape and taste as melatonin) at 9 pm as control group | Drug | Placebo |
Primary outcome
Change from baseline in weight at week eight
Time frame: Baseline and week eight
22 secondary outcomes
Change from baseline in Triglyceride at week 4
Time frame: Baseline and week 4
Change from baseline in HDL at week 4
Time frame: Baseline and week 4
Change from baseline in LDL at week 4
Time frame: Baseline and week 4
Change from baseline in Total Cholesterol at week 4
Time frame: Baseline and Week 4
Change from baseline in weight at week 4
Time frame: Baseline and week 4
Change from baseline in Fasting blood sugar at week 4
Time frame: Baseline and week 4
Change from baseline in blood pressure at week 4
Time frame: Baseline and week 4
Change from baseline in body mass index (BMI) at week 4
Time frame: Baseline and week 4
Change from baseline in waist to hip ratio at week 4
Time frame: Baseline and week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 4
Time frame: Baseline and week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 8
Time frame: Baseline and week 8
Change from baseline in Triglyceride at week 48
Time frame: Baseline and week 8
Change from baseline in HDL at week 8
Time frame: Baseline and week 8
Change from baseline in LDL at week 8
Time frame: Baseline and week 8
Change from baseline in Total Cholesterol at week 8
Time frame: Baseline and Week 8
Change from baseline in Fasting blood sugar at week 8
Time frame: Baseline and week 8
Change from baseline in blood pressure at week 8
Time frame: Baseline and week 8
Change from baseline in body mass index (BMI) at week 8
Time frame: Baseline and week 8
Change from baseline in waist to hip ratio at week 8
Time frame: Baseline and week 8
Change from baseline in Insulin at week 8
Time frame: Baseline and week 8
Number of adverse events at the end of the study in each group
Time frame: Baseline, week 4, and 8
Changes from baseline in HOMA-IR values at week 8
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Background: PubMed 16710316Raskind MA, Burke BL, Crites NJ, Tapp AM, Rasmussen DD. Olanzapine-induced weight gain and increased visceral adiposity is blocked by melatonin replacement therapy in rats. Neuropsychopharmacology. 2007 Feb;32(2):284-8. doi: 10.1038/sj.npp.1301093. Epub 2006 May 10.
- Background: PubMed 21869685Borba CP, Fan X, Copeland PM, Paiva A, Freudenreich O, Henderson DC. Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia. J Clin Psychopharmacol. 2011 Oct;31(5):653-8. doi: 10.1097/JCP.0b013e31822bb573.
- Background: PubMed 22527998Anderson G, Maes M. Melatonin: an overlooked factor in schizophrenia and in the inhibition of anti-psychotic side effects. Metab Brain Dis. 2012 Jun;27(2):113-9. doi: 10.1007/s11011-012-9307-9. Epub 2012 Apr 25.
- Derived from this study: PubMed 24607293Modabbernia A, Heidari P, Soleimani R, Sobhani A, Roshan ZA, Taslimi S, Ashrafi M, Modabbernia MJ. Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study. J Psychiatr Res. 2014 Jun;53:133-40. doi: 10.1016/j.jpsychires.2014.02.013. Epub 2014 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Jafar Modabbernia, MD study chair
Guilan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Schizophrenia, run by Guilan University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 9 Apr 2013. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight at week eight (time frame: Baseline and week eight). 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 NCT01593774, which also lists 4 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 9 Apr 2013.