Effect of Melatonin on Sleep Quality in Patients Dementia
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| ClinicalTrials.gov Identifier: NCT03066518 |
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Recruitment Status :
Completed
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
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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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Melatonin
Melatonin 5 mg, daily, eight weeks
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Drug: Melatonin 5 mg
Other Name: Benedorm |
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Placebo Comparator: placebo
Placebo, daily, eight weeks
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Other: Placebo |
- Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ]A self-administered questionnaire that provides an overall rating of sleep quality.
- Minimental test [ Time Frame: baseline and to the 8 weeks ]The original purpose is to allow physicians to standardize and quantify cognitive status.
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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.
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
| Study Director: | Guillermo Guajardo, MD | HUGonzález |
Publications:
| Responsible Party: | Rocio Morales Delgado, MD, Hospital Universitario Dr. Jose E. Gonzalez |
| ClinicalTrials.gov Identifier: | NCT03066518 History of Changes |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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melatonin sleep dementia cognition |
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Dementia Sleep Wake Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurologic Manifestations |
Signs and Symptoms Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |