Trial Outcomes & Findings for Cognitive Effects of Atomoxetine in Humans: Genetic Moderators (NCT NCT01498549)

Last Updated: 2017-07-11

Results Overview

Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.
Overall Study STARTED	39
Overall Study Atomoxetine 40 mg	39
Overall Study Atomoxetine 80 mg	37
Overall Study Sugar Pill 0 mg	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Sample n=39 Participants This is the summary of the total sample used in the crossover design.
Age, Continuous	41.21 years STANDARD_DEVIATION 7.47 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Participants that completed any arm in the crossover are included in the analysis.

Outcome measures

Outcome measures
Measure	Atomoxetine 40 mg n=39 Participants Atomoxetine 40 mg dose	Atomoxetine 80 mg n=37 Participants Atomoxetine 80 mg dose	Sugar Pill 0mg n=36 Participants Sugar pill 0mg dose
Rapid Visual Information Processing Descriminability	0.88 Proportion of Participants Standard Deviation 0.06	0.89 Proportion of Participants Standard Deviation 0.07	0.87 Proportion of Participants Standard Deviation 0.05
Rapid Visual Information Processing Response Bias	0.87 Proportion of Participants Standard Deviation 0.14	0.86 Proportion of Participants Standard Deviation 0.16	0.89 Proportion of Participants Standard Deviation 0.22

PRIMARY outcome

Timeframe: 2 years

Population: Participants that completed any arm in the crossover are included in the analysis, participants with valid observations at both indices are included in the calculation.

Outcome measures

Outcome measures
Measure	Atomoxetine 40 mg n=38 Participants Atomoxetine 40 mg dose	Atomoxetine 80 mg n=37 Participants Atomoxetine 80 mg dose	Sugar Pill 0mg n=36 Participants Sugar pill 0mg dose
Rapid Visual Information Processing: Mean Correct Response Latency	446.70 milliseconds Standard Deviation 106.84	452.64 milliseconds Standard Deviation 133.22	464.44 milliseconds Standard Deviation 113.07

Adverse Events

Atomoxetine 40 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Atomoxetine 80 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sugar Pill 0 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Atomoxetine 40 mg n=39 participants at risk Atomoxetine 40 mg dose	Atomoxetine 80 mg n=39 participants at risk Atomoxetine 80 mg dose	Sugar Pill 0 mg n=39 participants at risk Sugar pill 0 mg dose
General disorders nausea	0.00% 0/39 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	2.6% 1/39 • Number of events 1 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/39 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
General disorders headache	2.6% 1/39 • Number of events 1 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/39 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/39 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
General disorders other	2.6% 1/39 • Number of events 1 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	0.00% 0/39 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.	2.6% 1/39 • Number of events 1 • Adverse events were collected once for each of the three visits on all enrolled subjects. The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.

Additional Information

Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed

Yale University

Phone: (203) 937-4809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place