At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 60 enrolled

Drug / intervention

Atomoxetine +1 moredrug

Likely dose

Atomoxetine 5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00498173

NCT00498173Phase 3Completed

Compare CT.gov

Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism

Massachusetts General Hospital·interventional·Posted Jul 9, 2007·Updated Nov 14, 2025

In Brief

A Phase 3 clinical trial evaluating Atomoxetine and Placebo for Autism. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

This study will evaluate the effectiveness of atomoxetine in treating children with attention deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAutism

CountriesUnited States

CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2007

First PostedJul 2007

Primary CompletionOct 2015

TodayJul 2026

First PostedJul 9, 2007

Enrollment StartJul 1, 2007

Primary CompletionOct 1, 2015

TodayJul 2, 2026

Enrollment to primary: 8.3 yearsPosted 19.0 years ago

Interventions

Atomoxetinedrug

Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.

Placebodrug

Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.