Attention-Deficit/Hyperactivity DisorderADHDNCT01104623
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder
An observational study of Attention-Deficit/Hyperactivity Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: German speaking: Adults, age 18-50 years.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center for ADHD Research, Department of Psychiatry, Charite - University Medicine
Berlin, 14050
Michael Colla, PhD, ++49-30-8445 ext. 8704, michael.colla@charite.de
Daina Langner, PhD, ++49-30-8445 ext. 8478, daina.langner@charite.de
About this study
Official title: Phase 1 Study of Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- MediTECH Electronic GmbH, AudioProfiling, Dr. Joerg Langner
- Responsible party
- Principal investigator, Michael Colla, Charite University, Berlin, Germany
- Investigators
- Michael Colla, PhD, Study chair, Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104623
- Sponsor's protocol ID
- AiF KF2247401-AK9-1
- Acronym
- ADHD
- Status last verified
- Feb 2012
- First submitted
- 14 Apr 2010
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18082369Banse 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.
PubMed 8851745
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01104623
- Acronym / sponsor ID
- ADHD / AiF KF2247401-AK9-1
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- MediTECH Electronic GmbH, AudioProfiling, Dr. Joerg Langner
- Study start
- Apr 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- German speaking: Adults, age 18-50 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- Background: PubMed 18082369Hamdan 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.
- Background: PubMed 8851745Banse 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.
- ADHD - Voice AnalysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Center for ADHD Research, Department of Psychiatry, Charite - University Medicine
Berlin, Germany
Michael Colla, PhD study chair
Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit/Hyperactivity Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.