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Geodon for the Treatment of Refractory Social Anxiety Disorder (SAD)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215150
First received: September 20, 2005
Last updated: October 23, 2014
Last verified: April 2013
Results First Received: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Social Anxiety Disorder
Interventions: Drug: Ziprasidone
Drug: Sertraline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 3 periods

Period 1:   Open Label Phase
    Open Label Treatment  
STARTED     51 [1]
COMPLETED     21  
NOT COMPLETED     30  
Lost to Follow-up                 7  
Withdrawal by Subject                 1  
Did not complete a post base visit                 13  
Did not meet randomization criteria                 9  
[1] Number of subjects consented

Period 2:   Randomization Phase Ziprasidone
    Open Label Treatment  
STARTED     10  
COMPLETED     7  
NOT COMPLETED     3  
Lost to Follow-up                 2  
Withdrawal by Subject                 1  

Period 3:   Randomization Phase Placebo
    Open Label Treatment  
STARTED     11  
COMPLETED     10  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This is the intent to treat population consisting of subjects completing at least one post baseline visit.

Reporting Groups
  Description
Study Treatment 8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects

Baseline Measures
    Study Treatment  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.5  ± 10.3  
Gender  
[units: participants]
 
Female     15  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures

1.  Primary:   Brief Social Phobia Scale(BSPS)   [ Time Frame: Baseline, 8 and 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wei Zhang, MD
Organization: Duke University Medical Center
phone: (919) 684 5645
e-mail: wei.zhang@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215150     History of Changes
Other Study ID Numbers: Pro00012882, 6479
Study First Received: September 20, 2005
Results First Received: December 13, 2012
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration