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Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach

7. Juli 2020 aktualisiert von: Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai
The growing number of medications used to treat attention-deficit/hyperactivity disorder (ADHD) raises important questions about whether different medications have similar or different therapeutic mechanisms of action. We have recently shown that the stimulant methylphenidate (MPH) and the non-stimulant atomoxetine (ATX) produce clinical improvement via a common mechanism in motor cortex, and distinct actions in frontostriatal and midline cingulate-precuneus regions. These exciting findings offer a window into the common and unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments. However, the interpretation and clinical utility of these results would be greatly enhanced by in-depth investigation of the impact of the two treatments on relevant neural networks, and analyses which evaluate whether improvement is achieved via normalization or other adaptive changes in brain function.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The specific aims of this project are to use functional magnetic resonance imaging (fMRI) to determine the significance of activation changes over treatment related to clinical improvement, and the impact of treatment on neural connectivity within and between the anti-correlated frontostriatal 'task-positive' circuit and cingulate-precuneus 'task-negative' network. Our central hypotheses are that clinical improvement is associated with: (i) normalization of reduced connectivity of regions within the 'task-positive' network, with resultant increased inhibition of motor cortex, and (ii) normalization of low task-related connectivity in regions within the task-negative network for MPH and the 'task-positive' network for ATX.

This research proposes to test a model which posits a neurophysiological basis of mechanisms of response to stimulant and non-stimulant medications, and fits with our long term objectives of being able to match treatments to individual patients. Testing this model requires large samples of youth scanned using fMRI before and after treatment, and matched healthy controls also scanned twice. We will use an innovative network-based approach to study the effects of treatment, building on results from our current fMRI treatment study, and incorporating new theoretical approaches to understanding ADHD and its treatment.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

127

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Icahn School of Medicine at Mount Sinai

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

7 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

General inclusion criteria for subjects with ADHD and healthy controls are:

  • aged 7-17 years;
  • Wechsler Intelligence Scale for Children (WISC) scores ≥ 75;
  • informed consent and assent to study participation.

Specific inclusion criteria for youth with ADHD are:

  • diagnosis of ADHD, any subtype, determined by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL);
  • ADHD Rating Scale-IV-Parent Version: Investigator Administered (ADHD-RSIV) total score ≥ 1.5 SD above age and gender means for subtype
  • Clinical Global Impressions-ADHD-Severity (CGI-S) score > 4;
  • ADHD must be the primary diagnosis and focus of treatment, and the treatments offered in the study must not be contraindicated for the comorbid disorder.

Exclusion Criteria:

General exclusion criteria are:

  • history of head injury with loss of consciousness or any CNS disease that is likely to affect brain function;
  • diagnosis of autism or pervasive developmental, psychotic, major mood, and Tourette's disorder;
  • alcohol or drug abuse in the past 3 months or a positive urinary toxic screen on initial evaluation;
  • use of psychotropic medication within 2 weeks of the study (8 weeks for fluoxetine);
  • pre-existing medical or psychological condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity);
  • metal in the body that precludes scanning (e.g., braces, metal plate);
  • positive urine pregnancy test.

Specific exclusion criteria for the treatment trial include:

  • previous unsuccessful trial of MPH or ATX that was adequately dosed (≥ 1 mg/kg for MPH or 1.0 mg/kg for ATX) and of adequate duration (≥ 4 weeks);
  • abnormal findings on physical exam, or vital signs
  • pulse and blood pressure > 95% of age and gender mean;
  • inability to swallow capsules;
  • weight is < 20 kg or > 85 kg.

Specific exclusion criteria for control youth include:

  • no past history or current diagnosis of any psychiatric disorder, determined by the K-SADS-PL interview;
  • ADHD-RS-IV and CBCL scores for each symptom domain ≤ 1 SD of age and gender means.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: fMRI scans
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
Sonstiges: fMRI scans
2 fMRI scans 6-8 weeks apart
Experimental: Atomoxetine arm
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
Sonstiges: fMRI scans
2 fMRI scans 6-8 weeks apart
Arzneimittel: Atomoxetine arm
Flexible dose titration with atomoxetine prescribed at weekly visits for 6-8 weeks
Andere Namen:
  • Strattera
  • ATX
Experimental: Methylphenidate arm
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
Sonstiges: fMRI scans
2 fMRI scans 6-8 weeks apart
Arzneimittel: Methylphenidate arm
Flexible dose titration with methylphenidate for 6-8 weeks, with optional post study stabilization visits.
Andere Namen:
  • Konzert
  • MPH

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
Zeitfenster: Baseline and at 6 weeks
Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli ("go" stimuli) and make no response for others ("no-go" stimuli).
Baseline and at 6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)
Zeitfenster: 8 weeks
ADHD-RS is an 18-item list of core ADHD symptoms, each item are scored on a 4-point scale from 0-3, with total 0-54, with higher score indicating more symptoms.
8 weeks
Clinical Global Impressions-Severity (CGI-S)
Zeitfenster: up to 6 weeks
a clinician rated measure of symptom severity. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
up to 6 weeks
Response Time in Attention Networks Test (ANT)
Zeitfenster: baseline and at 6 weeks
A neuropsychological assessment of attention compared at 6 weeks from baseline by looking at response time. The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control. The response time were summed.
baseline and at 6 weeks
Continuous Performance Test (CPT)
Zeitfenster: baseline and at 6 weeks
A neuropsychological assessment of attention compared at 6 weeks from baseline. CPT is a task-oriented computerized assessment of attention-related problems.This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general. Scores are compared with the normative scores for the age, group and gender of the person being tested and represented as a commissioned T-score. The T-score indicates the degree to which performance in CPT task is higher or lower than the performance of a healthy individual matched in age. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more attention-related problems.
baseline and at 6 weeks
Digit Span
Zeitfenster: baseline and at 6 weeks
A cognitive/neuropsychological measure of auditory/verbal working memory compared at 6 weeks from baseline. Digit Span. Memory span is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. Memory span is a common measure of short-term memory. A digit-span task is used to measure working memory's number storage capacity.The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 0-16 points. Higher score indicates better health outcomes.
baseline and at 6 weeks
Finger Windows
Zeitfenster: baseline and at 6 weeks
A neuropsychological measure of motor skill and visual-spatial working memory compared at 6 weeks from baseline. The Finger Windows subtest is a measure of nonverbal, rote sequential recall. scaled scores ranging from 1 to 19, with higher score indicating better attention or concentration.
baseline and at 6 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Icahn School of Medicine at Mount Sinai

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: Kurt Schulz, PhD, Icahn School of Medicine at Mount Sinai

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2012

Primärer Abschluss (Tatsächlich)

30. April 2018

Studienabschluss (Tatsächlich)

30. April 2018

Studienanmeldedaten

Zuerst eingereicht

30. August 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. August 2012

Zuerst gepostet (Schätzen)

3. September 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2020

Zuletzt verifiziert

1. Juli 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GCO 11-0161
  • 5R01MH095766-02 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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