Trial Outcomes & Findings for Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility (NCT NCT00953862)

Last Updated: 2016-03-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline and week 10 of treatment

Results posted on

2016-03-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Atomoxetine Arm 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 Study STARTED	18
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=18 Participants 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.
Age, Continuous	36.8 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized African-American	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Substance Used Cocaine	6 Participants n=5 Participants
Substance Used Cannabis	5 Participants n=5 Participants
Substance Used Alcohol	3 Participants n=5 Participants
Substance Used Opioid	3 Participants n=5 Participants
Substance Used Other/Unable to report	1 Participants n=5 Participants
Length of Abstinence from all Substances	14.1 Weeks STANDARD_DEVIATION 18.5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 10 of treatment

Population: Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment

Outcome measures

Outcome measures
Measure	Atomoxetine Arm n=12 Participants 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.
Change in Adult ADHD Investigator Symptom Rating Scale Score	17.3 units on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: Baseline and week 10 of treatment

Population: Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment

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).

Outcome measures

Outcome measures
Measure	Atomoxetine Arm n=12 Participants 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.
Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score	19.7 units on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline and week 10 of treatment

Population: Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment

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).

Outcome measures

Outcome measures
Measure	Atomoxetine Arm n=12 Participants 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.
Change in Clinical Global Impression-- Severity of Illness Score	1.1 units on a scale Standard Deviation 0.9

Adverse Events

Treatment Phase

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Phase n=18 participants at risk 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.
Vascular disorders Headache	11.1% 2/18 The study results analyses for adverse events did not specify what "other" meant and will therefore be only presented as "other" without specification.
Gastrointestinal disorders Abdominal pain/cramps	11.1% 2/18 The study results analyses for adverse events did not specify what "other" meant and will therefore be only presented as "other" without specification.
General disorders Other	27.8% 5/18 The study results analyses for adverse events did not specify what "other" meant and will therefore be only presented as "other" without specification.

Additional Information

Dr. Lenard Adler

NYU School of Medicine

Phone: (212) 263-3580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place