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12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Medical Research Network
ClinicalTrials.gov Identifier:
NCT01316302
First received: March 14, 2011
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: September 30, 2014  
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: Pristiq
Drug: Placebo

  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
No text entered.

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
Pristiq

Flexible dose, 50-100mg QD

Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.

Placebo

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.


Participant Flow:   Overall Study
    Pristiq     Placebo  
STARTED     30     33  
COMPLETED     20     22  
NOT COMPLETED     10     11  



  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.
No text entered.

Reporting Groups
  Description
Pristiq

Flexible dose, 50-100mg QD

Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.

Placebo

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.

Total Total of all reporting groups

Baseline Measures
    Pristiq     Placebo     Total  
Number of Participants  
[units: participants]
  30     33     63  
Age  
[units: years]
Mean ± Standard Deviation
  39.9  ± 14.6     41.9  ± 13.7     40.0  ± 19.9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     33     63  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     16     13     29  
Male     14     20     34  
Region of Enrollment  
[units: participants]
     
United States     30     33     63  



  Outcome Measures

1.  Primary:   Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score   [ Time Frame: Baseline to study endpoint (Week 12) ]

2.  Secondary:   Clinical Global Impression of Improvement Scale (CGI-I)   [ Time Frame: Baseline to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Clinical Global Impression of Severity Scale (CGI-S)   [ Time Frame: Baseline to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change on the LSAS Anxiety and Avoidance Subscales   [ Time Frame: Baseline to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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: Michael R. Liebowitz, M.D.
Organization: The Medical Research Network, LLC
phone: (212) 595-5012
e-mail: MLiebowitz@MedicalResearchNetwork.com


No publications provided


Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT01316302     History of Changes
Other Study ID Numbers: PF2010SAD, WS1228302
Study First Received: March 14, 2011
Results First Received: September 30, 2014
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration