Trial Outcomes & Findings for Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS) (NCT NCT00181766)

Last Updated: 2019-08-21

Results Overview

The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

6 Weeks

Results posted on

2019-08-21

Participant Flow

Subjects were from referrals to the Adult ADHD Program at the MGH and through advertisements in the local media. The majority of subjects referred to our program first participate in our general screening protocol entitled, "A Screening Protocol for Adults with Attention Deficit Hyperactivity Disorder" (Protocol # 2002-P-001856).

Participant milestones

Participant milestones
Measure	Strattera (Atomoxetine) Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Overall Study STARTED	45
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Strattera (Atomoxetine) Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Overall Study Lost to Follow-up	6
Overall Study Adverse Event	4
Overall Study non-compliance	2

Baseline Characteristics

Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strattera (Atomoxetine) n=45 Participants Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Population: All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.

Outcome measures

Outcome measures
Measure	Strattera (Atomoxetine) n=45 Participants Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
ADHD-Clinical Global Impression	29 subjects

PRIMARY outcome

Timeframe: baseline and 6 Weeks

Population: All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.

The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.

Outcome measures

Outcome measures
Measure	Strattera (Atomoxetine) n=45 Participants Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
The Adult AISRS	-12.1 scores on a scale Standard Deviation 8.4

Adverse Events

Strattera (Atomoxetine)

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Strattera (Atomoxetine) n=45 participants at risk Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Gastrointestinal disorders Dry Mouth	57.8% 26/45
Gastrointestinal disorders Gastrointestinal	48.9% 22/45
General disorders Insomnia	48.9% 22/45
General disorders Tired/fatigued	48.9% 22/45
General disorders Headache	37.8% 17/45
Metabolism and nutrition disorders Decreased appetite	33.3% 15/45
Nervous system disorders Warmth/flushing/sweating	28.9% 13/45
Immune system disorders Colds/allergies/infections	24.4% 11/45
General disorders Lightheaded/dizzy	22.2% 10/45
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	20.0% 9/45
Nervous system disorders Tension/jitteriness	20.0% 9/45
Psychiatric disorders Mood change	15.6% 7/45
Reproductive system and breast disorders Sexual function	15.6% 7/45
Renal and urinary disorders Urinary hesitancy	13.3% 6/45
Nervous system disorders Neurologic	11.1% 5/45
Eye disorders Vision/ocular	11.1% 5/45
Nervous system disorders Feeling cold	8.9% 4/45
Injury, poisoning and procedural complications Injury	8.9% 4/45
Musculoskeletal and connective tissue disorders Muscle twitch/tremor	8.9% 4/45
Nervous system disorders Impaired concentration	6.7% 3/45
Cardiac disorders Palpitations	6.7% 3/45
Nervous system disorders Tingling sensation	6.7% 3/45
Psychiatric disorders Vivid dreams	6.7% 3/45
Psychiatric disorders Anxiety	4.4% 2/45
Nervous system disorders Bad taste	4.4% 2/45
Cardiac disorders Chest discomfort	4.4% 2/45
Skin and subcutaneous tissue disorders Skin changes	4.4% 2/45
Metabolism and nutrition disorders Increased appetite	2.2% 1/45
Nervous system disorders Paresthesia	2.2% 1/45
Respiratory, thoracic and mediastinal disorders Shortness of breath	2.2% 1/45
Renal and urinary disorders Urinary incontinence	2.2% 1/45

Additional Information

Joseph Biederman, MD

Massachusetts General Hospital

Phone: 617-726-1743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place