NCT00610259|CompletedPhase 2/3
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Sponsor study identifier
Secondary identifiers
interventional
40
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
August 2009
Actual (reported)The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2008
Actual (reported)February 7, 2008
Actual (reported)July 2009
Actual (reported)August 2009
Actual (reported)Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
at 8-week
"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score
at 8-week
"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score
at 4-week
Changes in the total ISI score between the baseline and the 4-week assessment
at 4-week
Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment
at 8-week
Changes in the total score of the modified PSQI between the baseline and the 4-week assessment
at 4-week
brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU)
Treatment as usual (TAU)
4 50-minute individual sessions every week for 4 weeks
The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi-ken, 467-8601, Japan
Shimodera S, Watanabe N, Furukawa TA, Katsuki F, Fujita H, Sasaki M, Perlis ML. Change in quality of life after brief behavioral therapy for insomnia in concurrent depression: analysis of the effects of a randomized controlled trial. J Clin Sleep Med. 2014 Apr 15;10(4):433-9. doi: 10.5664/jcsm.3624.
Watanabe N, Furukawa TA, Shimodera S, Morokuma I, Katsuki F, Fujita H, Sasaki M, Kawamura C, Perlis ML. Brief behavioral therapy for refractory insomnia in residual depression: an assessor-blind, randomized controlled trial. J Clin Psychiatry. 2011 Dec;72(12):1651-8. doi: 10.4088/JCP.10m06130gry. Epub 2011 Mar 8.
Toshiaki A Furukawa, MD, PhD
Nagoya City University Graduate School of Medical Sciences
First Submitted
January 16, 2008
First Posted
February 7, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
August 2009
Actual (reported)Last Updated
September 18, 2009
Record last verified: 2009-09
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