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Effects of Melatonin on Insomnia Symptoms in Older Adults

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00230737
First received: September 12, 2005
Last updated: January 17, 2017
Last verified: January 2017
Results First Received: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
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
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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
  Description
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 
Age 
[Units: Years]
Mean (Standard Deviation)
 73  (5.9)   75.7  (4.7)   75.1  (6.2)   74.6  (5.6) 
Gender 
[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
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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
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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
e-mail: ngoonera@upenn.edu


Publications of Results:

Responsible Party: Nalaka Gooneratne, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00230737     History of Changes
Other Study ID Numbers: R01AT001521-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: September 12, 2005
Results First Received: January 17, 2017
Last Updated: January 17, 2017