NCT01620866|Completed
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
BET
A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
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BET
A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
Sponsor study identifier
interventional
20
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
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.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2012
Actual (reported)June 2012
Actual (reported)June 11, 2012
Actual (reported)June 15, 2012
Actual (reported)The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group.
Patients with subsydromal symptoms, objectified by the YMRS and HDRS, are included in the study. After randomization to EMDR or TAU, group differences in changes in the YMRS and HRDS are measured at visit after intervention (3 months) and at follow-up (6 months). The hypothesize is that the EMDR group will statistically improve in both affective scales when compared to the TAU group.
3 months and 6 months
The EMDR group improves statistically significant in trauma load when compared to TAU.
3 months and 6 months
The EMDR group improves statistically significant in cognitive tests when compared to TAU.
3 months and 6 months
The EMDR group improves statistically significant in functioning when compared to TAU.
3 months and 6 months
The EMDR group improves statistically significant in quality of life when compared to TAU.
3 months and 6 months
Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.
3 months and 6 months
Treatment as usual (TAU)
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
FIDMAG
Barcelona, Barcelona, 08035, Spain
Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
Benedikt L Amann, MD
FIDMAG Germanes Hospitalàries
20 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2012
First Posted
June 15, 2012
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
June 19, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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