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CompletedPhase 4

Effect of Melatonin on Sleep Quality in Patients Dementia

A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Asset

Melatonin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age 60-95

Primary endpoint

•Pittsburgh Sleep Quality Index

Identifiers

Registered as

Org study IDGE15-002

NCT IDNCT03066518

Timeline

Milestones

Study start2016-01-15actual

Primary completion2017-01-25actual

Study completion2017-01-25actual

Study first posted2017-02-28actual

Last update posted2017-02-28actual

Assets

Drug assets

Melatonin

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Pittsburgh Sleep Quality Index

Time frame:8 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Minimental test

Time frame:baseline and to the 8 weeks

categorical status, descriptive

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.