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Effect of Melatonin on Sleep Quality in Patients Dementia

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ClinicalTrials.gov Identifier: NCT03066518
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Rocio Morales Delgado, Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:

Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.

Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.

Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.

Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).

Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.

Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).

Condition or disease Intervention/treatment Phase
Sleep Disorders Dementia Drug: Melatonin 5 mg Other: Placebo Phase 4

Detailed Description:

This is a single-center study. The study protocol, informed consents, and amendments were approved in writing by the appropriate local site Independent Ethics Committee (IEC)/Institutional Review Boards (IRB) (Ethics Committee of the Universidad Autónoma de Nuevo León, School of Medicine).

The patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. Following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. The treatment was double-blinded, with two parallel treatment groups. Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blinded, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Melatonin
Melatonin 5 mg, daily, eight weeks
Drug: Melatonin 5 mg
Other Name: Benedorm

Placebo Comparator: placebo
Placebo, daily, eight weeks
Other: Placebo

Primary Outcome Measures :
  1. Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ]
    A self-administered questionnaire that provides an overall rating of sleep quality.

Secondary Outcome Measures :
  1. Minimental test [ Time Frame: baseline and to the 8 weeks ]
    The original purpose is to allow physicians to standardize and quantify cognitive status.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Older than 60 years;
  • Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);
  • Mild or moderate dementia (clinical dementia rating 1 and 2);
  • Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.

Exclusion Criteria:

  • They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.

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): NCT03066518

Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
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Study Director: Guillermo Guajardo, MD HUGonzález

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rocio Morales Delgado, MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03066518    
Other Study ID Numbers: GE15-002
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rocio Morales Delgado, Hospital Universitario Dr. Jose E. Gonzalez:
Additional relevant MeSH terms:
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Sleep Wake Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants