The Serotonin Transporter in Attention Deficit Hyperactiv... | NCT01108354

Studies
The Serotonin Transporter in Attention Deficit Hyperactivity Disorder

NCT01108354

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 3, 2014Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Apr 20, 2010

First Submission Date that Met QC Criteria

Apr 21, 2010

First Posted Date

Apr 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2014

Last Update Posted Date

Jan 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

44Actual

Label	Type	Description	Intervention Names
ADHD patients		10 male adult ADHD patients and 10 female adult ADHD patients
healthy controls		20 age- and sex-matched healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-HTT-binding potential	5-HTT-binding potential in adult medication-free ADHD patients compared to a group of healthy controls	16 months

Secondary Outcomes

Measure	Description	Time Frame
SNPs	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]	16 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Psychotherapy, Medical University of Vienna		Vienna		A-1090	Austria

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders