CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Strattera (atomoxetine)drug
Likely dose
Atomoxetine up to 1.2 mg/kg orally once daily, maximum 120 mg once dailyAI-extracted
Key inclusion· 6
  • Age 18-54 years old
  • ADHD NOS diagnosis by DSM-IV, confirmed by structured interview: either ≥6/9 current inattention or hyperactivity/impulsivity items with <5 childhood items, OR 5/9 current items without 6 in either category
  • Clinical Global Impression ADHD score ≥4
  • Can have past depression/anxiety disorder if none currently for >3 months
Key exclusion· 10
  • Unstable psychiatric conditions: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, lifetime bipolar disorder, acute substance use, sociopathy, criminality
  • Metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine disease
  • Mental retardation (IQ <75)
  • Organic brain disorders

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

Search/NCT00181766
NCT00181766Phase 4Completed

A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified

Massachusetts General Hospital·interventional·Posted Sep 16, 2005·Updated Aug 21, 2019

In Brief

A Phase 4 clinical trial evaluating Strattera (atomoxetine) for ADHD NOS. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD NOS
CountriesUnited States

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartDec 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.8 years ago

Interventions

Strattera (atomoxetine)drug

Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).