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Trial Outcomes & Findings for Geodon for the Treatment of Refractory Social Anxiety Disorder (NCT NCT00215150)

NCT ID: NCT00215150

Last Updated: 2014-10-31

Results Overview

An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Baseline, 8 and 16 weeks

Results posted on

2014-10-31

Participant Flow

Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.

Participant milestones

Participant milestones
Measure
Open Label Treatment
8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
Open Label Phase
STARTED
51
Open Label Phase
COMPLETED
21
Open Label Phase
NOT COMPLETED
30
Randomization Phase Ziprasidone
STARTED
10
Randomization Phase Ziprasidone
COMPLETED
7
Randomization Phase Ziprasidone
NOT COMPLETED
3
Randomization Phase Placebo
STARTED
11
Randomization Phase Placebo
COMPLETED
10
Randomization Phase Placebo
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Open Label Treatment
8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
Open Label Phase
Lost to Follow-up
7
Open Label Phase
Withdrawal by Subject
1
Open Label Phase
Did not complete a post base visit
13
Open Label Phase
Did not meet randomization criteria
9
Randomization Phase Ziprasidone
Lost to Follow-up
2
Randomization Phase Ziprasidone
Withdrawal by Subject
1
Randomization Phase Placebo
Withdrawal by Subject
1

Baseline Characteristics

Geodon for the Treatment of Refractory Social Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Treatment
n=38 Participants
8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Age, Continuous
33.5 years
STANDARD_DEVIATION 10.3 • n=93 Participants
Sex: Female, Male
Female
15 Participants
n=93 Participants
Sex: Female, Male
Male
23 Participants
n=93 Participants
Region of Enrollment
United States
38 participants
n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 8 and 16 weeks

Population: The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.

An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.

Outcome measures

Outcome measures
Measure
Open Label Phase
n=38 Participants
The open label treatment phase for the first 8 weeks
Randomization Phase for Ziprasidone Group
n=10 Participants
The group of subjects randomized to receive Ziprasidone for the second 8 weeks
Randomization Phase for Placebo Group
n=11 Participants
The group of subjects randomized to receive placebo for the second 8 weeks
Brief Social Phobia Scale(BSPS)
End of Study Phase
31.2 units on a scale
Standard Deviation 16.0
21.0 units on a scale
Standard Deviation 13.6
24.6 units on a scale
Standard Deviation 12.3
Brief Social Phobia Scale(BSPS)
Beginning of Study Phase
44.0 units on a scale
Standard Deviation 11.1 • Interval 24.0 to 67.0
31.8 units on a scale
Standard Deviation 8.9 • Interval 18.0 to 47.0
31.8 units on a scale
Standard Deviation 11.8 • Interval 12.0 to 55.0

Adverse Events

Open Label Phase

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Randomization Phase for Ziprasidone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Randomization Phase for 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

Wei Zhang, MD

Duke University Medical Center

Phone: (919) 684 5645

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place