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Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics

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ClinicalTrials.gov Identifier: NCT01811160
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Francisco Romo Nava, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Second Generation Antipsychotic Induced Metabolic Adverse Effects Drug: Melatonin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Study Start Date : October 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin 5mg (extended release capsules)
Subjects received melatonin (extended release) 5mg nightly during the follow up period
Drug: Melatonin
A capsule of melatonin was administered nightly (20:00hrs).
Other Name: Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.

Placebo Comparator: Placebo
Subjects received a placebo capsule nightly during the eight week follow up period.
Drug: Placebo
Placebo capsules were administered at 20:00hrs for eight weeks




Primary Outcome Measures :
  1. Weight change [ Time Frame: Mean change from baseline weight at 8 weeks ]

Secondary Outcome Measures :
  1. Mean change in systolic blood pressure [ Time Frame: Mean change from baseline systolic blood pressure at 8 weeks ]
  2. Mean change diastolic blood pressure [ Time Frame: Mean change from baseline diastolic blood pressure at 8 weeks ]
  3. Mean change waist circumference [ Time Frame: Mean change from baseline waist circumference at 8 weeks ]
  4. Mean change hip circumference [ Time Frame: Mean change from baseline hip circumference at 8 weeks ]
  5. Mean change fat mass [ Time Frame: Mean change from baseline fat mass at 8 weeks ]
  6. Mean change lean mass [ Time Frame: Mean change from baseline lean mass at 8 weeks ]
  7. Mean change total body water [ Time Frame: Mean change from baseline total body water at 8 weeks ]
  8. Mean change glucose [ Time Frame: Mean change from baseline glucose at 8 weeks ]
  9. Mean change low density lipoprotein [ Time Frame: Mean change from baseline low density lipoprotein at 8 weeks ]
  10. Mean change high density lipoprotein [ Time Frame: Mean change from baseline high density lipoprotein at 8 weeks ]
  11. Mean change triglycerides [ Time Frame: Mean change from baseline triglycerides at 8 weeks ]
  12. Mean change cholesterol [ Time Frame: Mean change from baseline cholesterol at 8 weeks ]
  13. Mean change Hamilton D scores [ Time Frame: Mean change from baseline Hamilton D score at 8 weeks ]
  14. Mean change Young Mania rating scale [ Time Frame: Mean change from baseline Young Mania rating scale at 8 weeks ]
  15. Mean change Positive and Negative Symptoms scale [ Time Frame: Mean change from baseline Positive and Negative Symptoms scale at 8 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and non-pregnant, non-lactating women aged between 18 and 45 years;
  2. DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
  3. free of concomitant medical or neurological illness (as per review of systems and general physical examination);
  4. free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
  5. 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.

Exclusion Criteria:

  1. were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
  2. had a history of hypersensitivity to melatonin;
  3. exhibited high risk for suicide or high risk for aggressiveness;
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811160


Locations
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Mexico
Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"
Mexico City, México City, Mexico, 14370
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Investigators
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Principal Investigator: Francisco Romo-Nava, MD Instituto Nacional de Psiquiatría / UNAM

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Responsible Party: Francisco Romo Nava, MD, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier: NCT01811160     History of Changes
Other Study ID Numbers: INPRF_144
INPRF_144 ( Other Grant/Funding Number: Instituto Nacional de Psiquiatría No. 144 )
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Francisco Romo Nava, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:
Melatonin
Second generation antipsychotic
bipolar disorder
schizophrenia
Metabolic
Additional relevant MeSH terms:
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Melatonin
Antipsychotic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Tranquilizing Agents
Psychotropic Drugs