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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00050050
Other study ID # R03MH060940
Secondary ID R03MH060940DSIR
Status Completed
Phase Phase 1
First received November 20, 2002
Last updated May 23, 2014
Start date September 2001
Est. completion date August 2003

Study information

Verified date May 2014
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.

Study hypothesis: CBT is an effective treatment for adult ADHD.


Description:

ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.

Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2003
Est. primary completion date August 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult ADHD of at least moderate severity

- On current drug therapy for ADHD

Exclusion Criteria:

- Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders

- Current substance abuse or dependence

- IQ less than 90

- Suicide risk

- History of cognitive behavioral therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Behavioral:
Cognitive behavioral therapy

Drug:
Drug therapy


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ADHD symptoms
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