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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: August 23, 2016
Last verified: August 2016
Results First Received: September 30, 2014  
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: 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 
Overall Participants Analyzed 
[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
  Show All 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 ]

3.  Secondary:   Patient Global Impression of Change   [ Time Frame: Baseline to study endpoint (Week 12) ]


  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



Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT01316302     History of Changes
Other Study ID Numbers: PF2010SAD
WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
Study First Received: March 14, 2011
Results First Received: September 30, 2014
Last Updated: August 23, 2016