Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE

NCT00687609 | Terminated Phase 4 Results

• 2 other identifiers: 12382B4Z-UT-LYEL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse.

Conditions

Attention Deficit Hyperactivity Disorder; Cannabis Abuse

Keywords

Attention Deficit Hyperactivity Disorder with Cannabis Abuse; Marihuana Abuse; Comorbid Cannabis Abuse

Outcome Measures

Primary Outcomes (1)

• Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks

  Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.

  12 weeks

Secondary Outcomes (10)

• Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks

  12 weeks

• Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version

  Baseline, 12 weeks

• Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)

  Baseline, 12 weeks

• Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)

  Baseline, 12 weeks

• Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)

  Baseline, 12 weeks

Study Arms (1)

Atomoxetine

EXPERIMENTAL

0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.

Also known as: LY139603, Strattera

Atomoxetine

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis ADHD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
• At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
• Cannabis Abuse or dependence based on the DSM-IV-TR, and using a minimum of 5 joints per week

You may not qualify if:

• Weight under 20 kilograms (kg)
• Patients at serious suicidal risk
• Patients with alcohol or drug abuse (other than cannabis)
• Patients who in the investigator's judgement are likely to need psychotropic medication + psychotherapy apart from atomoxetine

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

The Hague, 2566 ER, Netherlands

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Marijuana Abuse

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited. Therefore, only disposition, demographic, and safety data are reported.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 24, 2010
• Results First Posted: August 19, 2010

Record last verified: 2010-08

Locations

NL (1)