Second Generation Antipsychotic Induced Metabolic Adverse EffectsPhase 4NCT01811160
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
A Phase 4 study testing Melatonin in people with Second Generation Antipsychotic Induced Metabolic Adverse Effects, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial summary
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Second Generation Antipsychotic Induced Metabolic Adverse Effects
- 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
- 50 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Nov 2011
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and non-pregnant, non-lactating women aged between 18 and 45 years;
- DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
- free of concomitant medical or neurological illness (as per review of systems and general physical examination);
- free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
- who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.
Who cannot join
- were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
- had a history of hypersensitivity to melatonin;
- exhibited high risk for suicide or high risk for aggressiveness;
- women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"
Mexico City, México City, 14370
About this study
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute and long term treatment of these disorders and are considered a first option on most treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality as well as non- adherence to treatment. There are several hypotheses attempting to explain the complex pathways that lead to antipsychotic therapeutic effects and their accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent the body weight increase, which indicates a possible role for biological rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that follows a circadian rhythm with an increased secretion in the middle of the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and periphery. Thus melatonin is involved in a series of biological functions such as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more recently in the regulation of metabolic processes including insulin, leptin, and lipid regulation.
Given previous results in experimental animals, the purpose of the present study is to test the potential effect of melatonin in reducing or preventing some of the metabolic disturbances associated with SGA
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Second generation antipsychotic, bipolar disorder, schizophrenia, Metabolic
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.
A capsule of melatonin was administered nightly (20:00hrs).
PlaceboDrug
Placebo capsules were administered at 20:00hrs for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 5mg (extended release capsules) | Experimental | Subjects received melatonin (extended release) 5mg nightly during the follow up period Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Subjects received a placebo capsule nightly during the eight week follow up period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: Mean change from baseline weight at 8 weeks
Secondary outcomes (15)
Mean change in systolic blood pressure
Measured: Mean change from baseline systolic blood pressure at 8 weeks
Mean change diastolic blood pressure
Measured: Mean change from baseline diastolic blood pressure at 8 weeks
Mean change waist circumference
Measured: Mean change from baseline waist circumference at 8 weeks
Mean change hip circumference
Measured: Mean change from baseline hip circumference at 8 weeks
Mean change fat mass
Measured: Mean change from baseline fat mass at 8 weeks
Mean change lean mass
Measured: Mean change from baseline lean mass at 8 weeks
Mean change total body water
Measured: Mean change from baseline total body water at 8 weeks
Mean change glucose
Measured: Mean change from baseline glucose at 8 weeks
Mean change low density lipoprotein
Measured: Mean change from baseline low density lipoprotein at 8 weeks
Mean change high density lipoprotein
Measured: Mean change from baseline high density lipoprotein at 8 weeks
Mean change triglycerides
Measured: Mean change from baseline triglycerides at 8 weeks
Mean change cholesterol
Measured: Mean change from baseline cholesterol at 8 weeks
Mean change Hamilton D scores
Measured: Mean change from baseline Hamilton D score at 8 weeks
Mean change Young Mania rating scale
Measured: Mean change from baseline Young Mania rating scale at 8 weeks
Mean change Positive and Negative Symptoms scale
Measured: Mean change from baseline Positive and Negative Symptoms scale at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startOct 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Generation Antipsychotic Induced Metabolic Adverse EffectsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Romo Nava, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- Francisco Romo-Nava, MD, Principal investigator, Instituto Nacional de Psiquiatría / UNAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811160
- Sponsor's protocol ID
- INPRF_144
- Other IDs
- INPRF_144
- Status last verified
- Mar 2013
- First submitted
- 28 Feb 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
- ClinicalTrials.gov ID
- NCT01811160
- Acronym / sponsor ID
- INPRF_144
- Keywords
- Melatonin, Second generation antipsychotic, bipolar disorder, schizophrenia, Metabolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Mar 2013 (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.
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute and long term treatment of these disorders and are considered a first option on most treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality as well as non- adherence to treatment. There are several hypotheses attempting to explain the complex pathways that lead to antipsychotic therapeutic effects and their accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent the body weight increase, which indicates a possible role for biological rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that follows a circadian rhythm with an increased secretion in the middle of the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and periphery. Thus melatonin is involved in a series of biological functions such as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more recently in the regulation of metabolic processes including insulin, leptin, and lipid regulation.
Given previous results in experimental animals, the purpose of the present study is to test the potential effect of melatonin in reducing or preventing some of the metabolic disturbances associated with SGA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin 5mg (extended release capsules) | Experimental | Drug: MelatoninSubjects received melatonin (extended release) 5mg nightly during the follow up period |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received a placebo capsule nightly during the eight week follow up period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and non-pregnant, non-lactating women aged between 18 and 45 years;
- DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
- free of concomitant medical or neurological illness (as per review of systems and general physical examination);
- free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
- who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.
Key exclusion criteria (4 listed)
- were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
- had a history of hypersensitivity to melatonin;
- exhibited high risk for suicide or high risk for aggressiveness;
- women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.
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 |
|---|---|---|
| MelatoninAlso: Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.A capsule of melatonin was administered nightly (20:00hrs). | Drug | Melatonin 5mg (extended release capsules) |
| PlaceboPlacebo capsules were administered at 20:00hrs for eight weeks | Drug | Placebo |
Primary outcome
Weight change
Time frame: Mean change from baseline weight at 8 weeks
15 secondary outcomes
Mean change in systolic blood pressure
Time frame: Mean change from baseline systolic blood pressure at 8 weeks
Mean change diastolic blood pressure
Time frame: Mean change from baseline diastolic blood pressure at 8 weeks
Mean change waist circumference
Time frame: Mean change from baseline waist circumference at 8 weeks
Mean change hip circumference
Time frame: Mean change from baseline hip circumference at 8 weeks
Mean change fat mass
Time frame: Mean change from baseline fat mass at 8 weeks
Mean change lean mass
Time frame: Mean change from baseline lean mass at 8 weeks
Mean change total body water
Time frame: Mean change from baseline total body water at 8 weeks
Mean change glucose
Time frame: Mean change from baseline glucose at 8 weeks
Mean change low density lipoprotein
Time frame: Mean change from baseline low density lipoprotein at 8 weeks
Mean change high density lipoprotein
Time frame: Mean change from baseline high density lipoprotein at 8 weeks
Mean change triglycerides
Time frame: Mean change from baseline triglycerides at 8 weeks
Mean change cholesterol
Time frame: Mean change from baseline cholesterol at 8 weeks
Mean change Hamilton D scores
Time frame: Mean change from baseline Hamilton D score at 8 weeks
Mean change Young Mania rating scale
Time frame: Mean change from baseline Young Mania rating scale at 8 weeks
Mean change Positive and Negative Symptoms scale
Time frame: Mean change from baseline Positive and Negative Symptoms scale at 8 weeks
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 14 Mar 2013.
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.
Francisco Romo-Nava, MD principal investigator
Instituto Nacional de Psiquiatría / UNAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Second Generation Antipsychotic Induced Metabolic Adverse Effects, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
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 5 inclusion and 4 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 14 Mar 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Weight change (time frame: Mean change from baseline weight at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2013.