- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01104623
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)
Phase 1 Study of Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)
Study Overview
Status
Conditions
Detailed Description
This project aims to develop an objective diagnostic instrument for ADHD through an automatic voice-analysis system, which uses as input the natural speech of the participants. The underlying voice-analysis procedure was developed by J. Langner at Humboldt University of Berlin (Langner 2003). It ignores the semantic content of spoken words and extracts prosodic and sound features from the speech.
Aims of the study:
- deliver optimized multivariate logistic regression models of prosodic and sound properties of speech for ADHD.
- observe sensitivity and specificity of the voice-analysis procedure.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Berlin, Germany, 14050
- Recruiting
- Center for ADHD Research, Department of Psychiatry, Charite - University Medicine
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Contact:
- Michael Colla, PhD
- Phone Number: 8704 ++49-30-8445
- Email: michael.colla@charite.de
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Contact:
- Daina Langner, PhD
- Phone Number: 8478 ++49-30-8445
- Email: daina.langner@charite.de
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Principal Investigator:
- Michael Colla, PhD
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Principal Investigator:
- Daina Langner, PhD
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Principal Investigator:
- Laura Gentschow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-50.
- Written informed consent.
- Adult ADHD / Non-ADHD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
- Normal vocal functioning, negative history for voice or laryngeal disorders.
- Currently euthyroid condition; in case of past history of thyroid disease and need for current pharmacological treatment, patient needs to be on stable medication for at least 4 weeks.
Exclusion Criteria:
- Exclusion of borderline and antisocial personality disorder, assessed by the German version of the SCID-II (Fydrich et al., 1997).
- Exclusion of schizophrenia and psychotic disorders not otherwise specified.
- Exclusion of Epilepsia.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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ADHD - Patients
Adults (18-50 years old).
All eligible subjects will experience the voice recording procedure followed by the assessment of adult ADHD diagnostics.
The diagnostic guidelines for ADHD in adulthood will be accomplished as outlined by expert consensus of the German Society for Psychiatry, Psychotherapy and Neurology, with a semi-structured clinical interview following the DSM-IV-TR criteria and the ADHD-Checklist (ADHD-CL) for DSM-IV (Hesslinger et al., 2002) to assess the severity of ADHD-Symptoms.
Childhood ADHD symptoms will be rated retrospectively amongst others by using the short version (WURS-k) of the Wender Utah Rating Scale (Ward et al., 1993), German version (Retz-Junginger et al., 2002).
To strengthen the validity of the ADHD diagnosis the reported symptoms were corroborated by second party reports.
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Healthy Controls
Adults(18-50 years old).
All eligible subjects will experience the voice recording procedure followed by the ADHD-Checklist (ADHD-CL) for DSM-IV (Hesslinger et al., 2002.
To assess the severity of Non-ADHD, the absence of childhood ADHD symptoms will be rated retrospectively amongst others by using the short version (WURS-k) of the Wender Utah Rating Scale (Ward et al., 1993), German version (Retz-Junginger et al., 2002).
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Collaborators and Investigators
Investigators
- Study Chair: Michael Colla, PhD, Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Berlin
Publications and helpful links
General Publications
- Hamdan AL, Deeb R, Sibai A, Rameh C, Rifai H, Fayyad J. Vocal characteristics in children with attention deficit hyperactivity disorder. J Voice. 2009 Mar;23(2):190-4. doi: 10.1016/j.jvoice.2007.09.004. Epub 2007 Dec 21.
- Banse R, Scherer KR. Acoustic profiles in vocal emotion expression. J Pers Soc Psychol. 1996 Mar;70(3):614-36. doi: 10.1037//0022-3514.70.3.614.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AiF KF2247401-AK9-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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