The Serotonin Transporter in Attention Deficit Hyperactivity Disorder
This study is currently recruiting participants.
Verified November 2011 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01108354
First received: April 20, 2010
Last updated: November 15, 2011
Last verified: November 2011
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Purpose
The aim of the present proposal is to prove that adult attention deficit hyperactivity disorder (ADHD) patients show lower serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT binding will be quantified in 20 adult medication-free ADHD patients (50% females) and in 20 age- and sexmatched healthy controls. Investigating untreated adult ADHD patients without any psychiatric comorbidities will provide the opportunity to estimate the change of serotonin transporter binding in adult ADHD patients compared to a group of healthy controls. Several lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition to dopamine, play an important role in the aetiology of ADHD. So far, no PET study investigating serotonergic neurotransmission in adult ADHD patients has been conducted, although alterations in the serotonin system may be substantially involved in the susceptibility and subtype characterization of ADHD.
| Condition |
|---|
|
Attention Deficit Hyperactivity Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | The Serotonin Transporter in Attention Deficit Hyperactivity Disorder Investigated With Positron Emission Tomography |
Resource links provided by NLM:
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
Drug Information available for:
Serotonin
U.S. FDA Resources
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- 5-HTT-binding potential [ Time Frame: 16 months ] [ Designated as safety issue: No ]5-HTT-binding potential in adult medication-free ADHD patients compared to a group of healthy controls
Secondary Outcome Measures:
- SNPs [ Time Frame: 16 months ] [ Designated as safety issue: No ]Single nucleotide polymorphisms (SNPs)of three genes, the serotonin transporter gene (SLC6A4), the 5-HT1A receptor gene[(-1018)G>C], and the 5-HT2A receptor gene [102T/C]
Biospecimen Retention: Samples With DNA
whole blood
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ADHD patients
10 male adult ADHD patients and 10 female adult ADHD patients
|
|
healthy controls
20 age- and sex-matched healthy volunteers
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
40 participants including ten male adult ADHD patients, ten female adult ADHD patients and 20 age- and sex-matched healthy volunteers, free of any psychotropic treatments at baseline
Criteria
Inclusion Criteria:
- Patients must be male or female outpatients who are at least 18 years of age and no more than 65 years of age when informed consent is obtained.
- Patients must meet DSM-IV-TR criteria for current ADHD as well as for historical diagnosis of ADHD during childhood as assessed by the Conner´s Adult ADHD Diagnostic Interview for DSM-IV (CAADID, Conners 1999).
- Patients must have a score of >2 on at least 6 items of either the inattentive or hyperactive score subscales at screening on the rated CAARS-Inv:SV (Conners 1999). In addition, their CAARS-Inv:SV 18-item total ADHD symptom score (the sum of the inattention and hyperactivity/impulsivity subscales) must be >20.
- Patients must have a CGI-ADHD-S score of >4 (moderate symptoms) at screening.
- Patients must be physically healthy.
- Patients must be able to understand and willing to sign the written informed consent document.
Exclusion Criteria:
- Patients suffering from severe somatic diseases will be excluded from the study.
- Any treatment with stimulants, selective norepinephrine reuptake inhibitors or any other psychotropic treatments, such as SSRIs, etc. within six months prior to screening.
- Patients suffering from any current comorbid psychiatric disorder (Axis I or Axis II diagnosis according to DSM-IV-TR) will be excluded.
- Patients who are currently using alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-IV-TR criteria for alcohol or other substance dependence.
- Any implant or stainless steel graft.
- Positive urine pregnancy test.
- Participation in studies with PET or SPECT within the last 10 years.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108354
Locations
| Austria | |
| Department of Psychiatry and Psychotherapy, Medical University of Vienna | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Siegfried Kasper, MD, Prof. +43-1-40400-3568 sci-biolpsy@meduniwien.ac.at | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| Principal Investigator: | Markus Mitterhauser, PhD A/Prof | Medical University of Vienna |
| Principal Investigator: | Alexandra Kutzelnigg, MD | Medical University of Vienna |
| Principal Investigator: | Rupert Lanzenberger, MD. A/Prof | Medical University of Vienna |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01108354 History of Changes |
| Other Study ID Numbers: | AP13675ONB |
| Study First Received: | April 20, 2010 |
| Last Updated: | November 15, 2011 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Serotonin Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013