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

7 luglio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

127

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti, 10029
        • Icahn School of Medicine at Mount Sinai

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 7 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: fMRI scans
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
Altro: fMRI scans
2 fMRI scans 6-8 weeks apart
Sperimentale: 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.
Altro: fMRI scans
2 fMRI scans 6-8 weeks apart
Droga: Atomoxetine arm
Flexible dose titration with atomoxetine prescribed at weekly visits for 6-8 weeks
Altri nomi:
  • Strattera
  • ATX
Sperimentale: 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.
Altro: fMRI scans
2 fMRI scans 6-8 weeks apart
Droga: Methylphenidate arm
Flexible dose titration with methylphenidate for 6-8 weeks, with optional post study stabilization visits.
Altri nomi:
  • Concerto
  • MPH

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2012

Completamento primario (Effettivo)

30 aprile 2018

Completamento dello studio (Effettivo)

30 aprile 2018

Date di iscrizione allo studio

Primo inviato

30 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2012

Primo Inserito (Stima)

3 settembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2020

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GCO 11-0161
  • 5R01MH095766-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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