Last reviewed · How we verify
NCT02259517
Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
NA trial testing Guanfacine in Attention Deficit Hyperactivity Disorder in 38 participants. Terminated before completion.
6 November 2021
Quick facts
| Lead sponsor | New York State Psychiatric Institute |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 1 September 2014 |
| Primary completion | 6 November 2021 |
| Estimated completion | 6 November 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Guanfacine (GUANFACINE) — full drug profile →
- Lisdexamfetamine (LISDEXAMFETAMINE) — full drug profile →
Conditions studied
- Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
Sponsor
New York State Psychiatric Institute
Who can join
Adults 6 to 17, any sex, with Attention Deficit Hyperactivity Disorder. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD
Time frame: Baseline and 6 weeks
Brain segmentation volume measured in mm\^3. We are reporting the mean difference in brain segmentation volume from baseline (pre-test) to 6 weeks (post-test). No statistical analysis information is being submitted for the affected outcome measure. No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollm
Sponsor's own description
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that both medications are effective in reducing ADHD symptoms, although the neurobiological mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02259517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Guanfacine
Trials testing the same drug.
- NCT06408246 — ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression · Phase 2 · recruiting
- NCT04742673 — Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study · Phase 2 · completed
- NCT04578886 — The Effect of Guanfacine on Delirium in Critically Ill Patients · Phase 3 · completed
- NCT03865940 — Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy · Phase 2 · completed
- NCT03980184 — Guanfacine to Improve Substance Use Outcomes in Women · Phase 2 · completed
Other recruiting trials for Attention Deficit Hyperactivity Disorder
Currently open trials in the same condition.
- NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact · Phase 1 · recruiting
- NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure · NA · recruiting
- NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
- NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
- NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting
Other New York State Psychiatric Institute trials
Trials by the same sponsor.
- NCT05416658 — Shared Decision Making for Antipsychotic Medications · NA · not yet recruiting
- NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia · Phase 1, PHASE2 · not yet recruiting
- NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual · Phase 2 · not yet recruiting
- NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD · Phase 2 · suspended
- NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02259517 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
- Last refreshed: 18 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02259517.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing