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The Serotonin Transporter in Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01108354
First received: April 20, 2010
Last updated: January 2, 2014
Last verified: January 2014

April 20, 2010
January 2, 2014
April 2010
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01108354 on ClinicalTrials.gov Archive Site
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]
Same as current
Not Provided
Not Provided
 
The Serotonin Transporter in Attention Deficit Hyperactivity Disorder
The Serotonin Transporter in Attention Deficit Hyperactivity Disorder Investigated With Positron Emission Tomography

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Non-Probability Sample

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

Attention Deficit Hyperactivity Disorder
Not Provided
  • ADHD patients
    10 male adult ADHD patients and 10 female adult ADHD patients
  • healthy controls
    20 age- and sex-matched healthy volunteers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01108354
AP13675ONB
Yes
Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
Not Provided
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
Medical University of Vienna
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP