CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Melatonin 0.4 mg +2 moredrug
Likely dose
Melatonin 0.4 mg or 4.0 mgAI-extracted
Key inclusion· 2
  • ✓History of insomnia
  • ✓Low melatonin levels at study entry
Key exclusion· 8
  • ✕History of sleep apnea
  • ✕Diagnosis of restless legs syndrome
  • ✕Current alcohol or substance abuse
  • ✕Dementia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00230737
NCT00230737Phase 2Completed
CompareCT.gov

Melatonin Randomized Trial for Insomnia in the Elderly

Nalaka Gooneratne·interventional·Posted Oct 3, 2005·Updated Mar 8, 2017

In Brief

A Phase 2 clinical trial evaluating Melatonin 0.4 mg, Melatonin 4.0 mg, and 1 other intervention for Sleep Initiation and Maintenance Disorders. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Initiation and Maintenance Disorders
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2005
Enrollment StartOct 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.7 years ago

Interventions

Melatonin 0.4 mgdrug

Melatonin 4.0 mgdrug

Placebodrug