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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215150
First Posted: September 22, 2005
Last Update Posted: October 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
Results First Submitted: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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 ( Other Identifier: Duke legacy protocol number )
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: December 13, 2012
Results First Posted: May 24, 2013
Last Update Posted: October 31, 2014