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Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility

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ClinicalTrials.gov Identifier: NCT00953862
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Atomoxetine
Enrollment 18
Recruitment Details Study participants were adult Odyssey House residents who met DSM-IV criteria for ADHD based on the Adult ADHD Clinician Diagnostic Scale v1.2 (ACDS v1.2) and drug and/or alcohol dependence based on Structured Clinical Interview for DSM Disorders - Patient Edition (SCID-I/P). Study was conducted from July 2005 to February 2007.
Pre-assignment Details Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, as assessed by clinical history and the SCID-I/P; seizure history (other than febrile seizures); current chronic or acute illness or medical condition, glaucoma, organic brain disease, traumatic brain injury, pregnancy, or lactation.
Arm/Group Title Atomoxetine Arm
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Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.

Period Title: Overall Study
Started 18
Completed 12
Not Completed 6
Arm/Group Title Treatment
Hide Arm/Group Description

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
This number is the total number who were found eligible for the treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
36.8  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
African-American 12
Caucasian 3
Hispanic 3
Substance Used  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Cocaine 6
Cannabis 5
Alcohol 3
Opioid 3
Other/Unable to report 1
Length of Abstinence from all Substances  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 18 participants
14.1  (18.5)
1.Primary Outcome
Title Change in Adult ADHD Investigator Symptom Rating Scale Score
Hide Description The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).
Time Frame Baseline and week 10 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment
Arm/Group Title Atomoxetine Arm
Hide Arm/Group Description:
Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.3  (11.9)
2.Secondary Outcome
Title Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score
Hide Description The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).
Time Frame Baseline and week 10 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment
Arm/Group Title Atomoxetine Phase
Hide Arm/Group Description:

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.7  (18.7)
3.Secondary Outcome
Title Change in Clinical Global Impression-- Severity of Illness Score
Hide Description The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
Time Frame Baseline and week 10 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment
Arm/Group Title Atomoxetine Arm
Hide Arm/Group Description:

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description The study results analyses for adverse events did not specify what "other" meant and will therefore be only presented as "other" without specification.
 
Arm/Group Title Treatment Phase
Hide Arm/Group Description

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.

All-Cause Mortality
Treatment Phase
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Phase
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Phase
Affected / at Risk (%)
Total   9/18 (50.00%) 
Gastrointestinal disorders   
Abdominal pain/cramps *  2/18 (11.11%) 
General disorders   
Other *  5/18 (27.78%) 
Vascular disorders   
Headache * 1  2/18 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Headache
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lenard Adler
Organization: NYU School of Medicine
Phone: (212) 263-3580
EMail: lenard.adler@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00953862     History of Changes
Other Study ID Numbers: IRB#12233
BAZ-US-X031
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: April 11, 2013
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016