Trial Outcomes & Findings for Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder (NCT NCT00260533)

Results Overview

This is a commonly used, clinician-rated measure of clinical improvement. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders".

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

27 participants

Primary outcome timeframe

10 weeks (end of study)

Results posted on

2016-06-24

Participant Flow

Outpatient recruitment.

Participant milestones

Participant milestones
Measure	Atomoxetine Atomoxetine 40-100 mg per day	Placebo Placebo (matched capsules to atomoxetine)
Overall Study STARTED	14	13
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Atomoxetine Atomoxetine 40-100 mg per day	Placebo Placebo (matched capsules to atomoxetine)
Overall Study Other	3	3

Baseline Characteristics

Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine n=14 Participants Atomoxetine	Placebo n=13 Participants Placebo	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks (end of study)

This is a commonly used, clinician-rated measure of clinical improvement. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders".

Outcome measures

Outcome measures
Measure	Atomoxetine n=14 Participants Atomoxetine	Placebo n=13 Participants Placebo
Clinical Global Impression (Change Version, Also Known as Improvement Version)	3 participants	4 participants

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Murray B. Stein MD, MPH

University of California San Diego

Phone: 858-534-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place