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
  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:


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


Enrollment: 44
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108354

Locations
Austria
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria, A-1090
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: January 2, 2014
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 July 20, 2014