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Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder (SAM-SAD)
This study has been completed.
Study NCT00502320   Information provided by Lehigh Valley Hospital

First Received on July 13, 2007.   Last Updated on October 2, 2009   History of Changes
Results First Received: July 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Seasonal Affective Disorder
Interventions: Drug: Ramelteon
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
Recruitment began in August 2006 and was completed by October 2007. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received no compensation for participating in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
50 individuals signed the informed consent document, one was a screen failure, so 49 participants started study medication. During the study, both treatment groups were maintained on their usual medications for depression and allowed treatment as usual, including medication adjustments.

Reporting Groups
  Description
Ramelteon 8 mg pill taken by mouth nightly
Placebo inactive sugar pill taken by mouth nightly

Participant Flow:   Overall Study
    Ramelteon     Placebo  
STARTED     25     25  
Screening Visit     25     24 [1]
COMPLETED     19     18  
NOT COMPLETED     6     7  
Lost to Follow-up                 1                 1  
Withdrew Consent                 1                 0  
No longer met criteria                 1                 0  
Screen Failure                 0                 1  
Adverse Event                 3                 5  
[1] Participant signed informed consent but was a screen failure because she was nursing at the time.



  Baseline Characteristics
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Reporting Groups
  Description
Ramelteon 8 mg pill taken by mouth nightly
Placebo inactive sugar pill taken by mouth nightly

Baseline Measures
    Ramelteon     Placebo     Total  
Number of Participants  
[units: participants]
 		  25     25     50  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     25     25     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.49  ± 11.81     47.76  ± 10.23     46.08  ± 11.04  
Gender  
[units: participants]
 		     
Female     19     18     37  
Male     6     7     13  
Region of Enrollment  
[units: participants]
 		     
United States     25     25     50  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: Monthly for duration of treatment (up to 4 months) ]
  Show Outcome Measure 1

2.  Secondary:   Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)   [ Time Frame: Monthly for duration of treatment (up to 4 months) ]
  Show Outcome Measure 2

3.  Secondary:   Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)   [ Time Frame: Monthly for duration of treatment (up to 4 months) ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Edward R. Norris, MD
Organization: Lehigh Valley Hospital
phone: 610-402-5766
e-mail: Edward.Norris@lvh.com


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McClung CA. Circadian genes, rhythms and the biology of mood disorders. Pharmacol Ther. 2007 May;114(2):222-32. Epub 2007 Feb 28. Review.
Michalak EE, Wilkinson C, Dowrick C, Wilkinson G. Seasonal affective disorder: prevalence, detection and current treatment in North Wales. Br J Psychiatry. 2001 Jul;179:31-4.
Michalak EE, Murray G, Levitt AJ, Levitan RD, Enns MW, Morehouse R, Tam EM, Cheung A, Lam RW. Quality of life as an outcome indicator in patients with seasonal affective disorder: results from the Can-SAD study. Psychol Med. 2007 May;37(5):727-36. Epub 2006 Nov 20.
Modell JG, Rosenthal NE, Harriett AE, Krishen A, Asgharian A, Foster VJ, Metz A, Rockett CB, Wightman DS. Seasonal affective disorder and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry. 2005 Oct 15;58(8):658-67.
Moscovitch A, Blashko CA, Eagles JM, Darcourt G, Thompson C, Kasper S, Lane RM; International Collaborative Group on Sertraline in the Treatment of Outpatients with Seasonal Affective Disorders. A placebo-controlled study of sertraline in the treatment of outpatients with seasonal affective disorder. Psychopharmacology (Berl). 2004 Feb;171(4):390-7. Epub 2003 Sep 19.
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Responsible Party: Edward R. Norris, MD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00502320     History of Changes
Other Study ID Numbers: 06-006R
Study First Received: July 13, 2007
Results First Received: July 21, 2009
Last Updated: October 2, 2009
Health Authority: United States: Institutional Review Board





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