Effects of Melatonin on Insomnia Symptoms in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230737
Recruitment Status : Completed
First Posted : October 3, 2005
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sleep Initiation and Maintenance Disorders
Interventions: Drug: Melatonin 0.4 mg
Drug: Melatonin 4.0 mg
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
A: Low Dose Melatonin 0.4 mg
B: High Dose Melatonin 4.0 mg
C: Control Placebo

Participant Flow:   Overall Study
    A: Low Dose   B: High Dose   C: Control
STARTED   9   10   8 
COMPLETED   9   10   8 
NOT COMPLETED   0   0   0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
A: Low Dose Melatonin 0.4 mg
B: High Dose Melatonin 4.0 mg
C: Control Placebo
Total Total of all reporting groups

Baseline Measures
   A: Low Dose   B: High Dose   C: Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   10   8   27 
[Units: Years]
Mean (Standard Deviation)
 73  (5.9)   75.7  (4.7)   75.1  (6.2)   74.6  (5.6) 
[Units: Participants]
Count of Participants
Female      6  66.7%      7  70.0%      7  87.5%      20  74.1% 
Male      3  33.3%      3  30.0%      1  12.5%      7  25.9% 
Region of Enrollment 
[Units: Participants]
United States   9   10   8   27 

  Outcome Measures

1.  Primary:   Peak Melatonin Level   [ Time Frame: day 42 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study did not meet total recruitment targets

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Nalaka Gooneratne
Organization: University of Pennsylvania
phone: 2674083789

Publications of Results:

Responsible Party: Nalaka Gooneratne, University of Pennsylvania Identifier: NCT00230737     History of Changes
Other Study ID Numbers: R01AT001521-01A1 ( U.S. NIH Grant/Contract )
R01AT001521-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: October 3, 2005
Results First Submitted: January 17, 2017
Results First Posted: March 8, 2017
Last Update Posted: March 8, 2017