NCT01629355|Completed
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Sponsor study identifier
observational
66
1 country
2
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
August 2015
Actual (reported)The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2012
Actual (reported)June 27, 2012
Actual (reported)July 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 2015
Actual (reported)August 2015
Actual (reported)SD-BERA patterns identified by SensoDetect using specific software
The Auditory Brainstem Response examination (SD-BERA) will be conducted once for each patient following his/her inclusion in the study
Brainstem potential patterns following an array of acoustic stimuli during a 25 min. examination
Five patients with diagnosed schizophrenia will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with schizophrenia will then be studied blindly to evaluate the predictive value of the test.
Five patients with diagnosed ADHD will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern.
Five patients with diagnosed Bipolar disorder will be used to map changes in ABR/SD-BERA potentials compared to controls to establish the disease-specific pattern. Twelve patients with Bipolar disorder will then be studied blindly to evaluate the predictive value of the test.
Fifteen healthy controls will be used to define normal pattern of ABR/SD-BERA potentials. Another twelve normal controls will be studied blindly to evaluate the predictive value of the test.
Patients recruited from the University Hospital of North Norway and the General Practice Clinic in Balsfjord, Troms, Norway. Healthy controls from North Norway.
Balsfjord Legekontor
Balsfjord, Troms, Norway
University Hospital North Norway
Tromsø, Troms, 9009, Norway
Wahlstrom V, Ahlander F, Wynn R. Auditory brainstem response as a diagnostic tool for patients suffering from schizophrenia, attention deficit hyperactivity disorder, and bipolar disorder: protocol. JMIR Res Protoc. 2015 Feb 12;4(1):e16. doi: 10.2196/resprot.3880.
Rolf Wynn, M.D., Ph.D.
University Hospital of North Norway
66 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2012
First Posted
June 27, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
September 1, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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