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Trial record 16 of 89 for:    DESVENLAFAXINE

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

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ClinicalTrials.gov Identifier: NCT01316302
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : October 8, 2014
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Medical Research Network

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
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pristiq Placebo
Hide Arm/Group Description

Flexible dose, 50-100mg QD

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

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.

Period Title: Overall Study
Started 30 33
Completed 20 22
Not Completed 10 11
Arm/Group Title Pristiq Placebo Total
Hide Arm/Group Description

Flexible dose, 50-100mg QD

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

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 30 33 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 33 participants 63 participants
39.9  (14.6) 41.9  (13.7) 40.0  (19.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
33
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Female
16
  53.3%
13
  39.4%
29
  46.0%
Male
14
  46.7%
20
  60.6%
34
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 33 participants 63 participants
30 33 63
1.Primary Outcome
Title Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
Hide Description Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
Time Frame Baseline to study endpoint (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).
Arm/Group Title Pristiq Placebo
Hide Arm/Group Description:

Flexible dose, 50-100mg QD

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

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.

Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Mean baseline LSAS total 93.4  (17.1) 92.1  (16.8)
Endpoint LSAS total 55.0  (27.4) 63.4  (22.1)
Mean LSAS change from baseline 38.4  (28.8) 28.7  (24.2)
2.Secondary Outcome
Title Clinical Global Impression of Improvement Scale (CGI-I)
Hide Description CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pristiq Placebo
Hide Arm/Group Description:
Flexible dose, 50-100mg QD
Matching placebo
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: % of subjects who were CGI-I responders
69 48.3
3.Secondary Outcome
Title Patient Global Impression of Change
Hide Description Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.
Time Frame Baseline to study endpoint (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pristiq Placebo
Hide Arm/Group Description:
Flexible dose, 50-100mg QD
Matching placebo
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: percentage of self-rated responders
44.8 40.7
Time Frame 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pristiq Placebo
Hide Arm/Group Description

Flexible dose, 50-100mg QD

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

Matching placebo

Placebo: Matching placebo, taken QD for 12 weeks.

All-Cause Mortality
Pristiq Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pristiq Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events .06%
Pristiq Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/30 (86.67%)      25/33 (75.76%)    
Gastrointestinal disorders     
indigestion   4/30 (13.33%)  4 1/33 (3.03%)  2
General disorders     
dizziness/lightheadedness/feeling faint   11/30 (36.67%)  12 4/33 (12.12%)  6
nausea/queasiness   11/30 (36.67%)  16 3/33 (9.09%)  3
drowsiness   7/30 (23.33%)  9 2/33 (6.06%)  2
headache   4/30 (13.33%)  6 5/33 (15.15%)  6
fatigue   4/30 (13.33%)  4 4/33 (12.12%)  5
decreased appetite   6/30 (20.00%)  7 1/33 (3.03%)  1
flu/flu symptoms   2/30 (6.67%)  2 3/33 (9.09%)  3
soft stools/diarrhea   5/30 (16.67%)  5 0/33 (0.00%)  0
dry mouth   3/30 (10.00%)  3 1/33 (3.03%)  1
Nervous system disorders     
insomnia   5/30 (16.67%)  8 4/33 (12.12%)  4
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Michael R. Liebowitz, M.D.
Organization: The Medical Research Network, LLC
Phone: (212) 595-5012
EMail: MLiebowitz@MedicalResearchNetwork.com
Layout table for additonal information
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. )
First Submitted: March 14, 2011
First Posted: March 16, 2011
Results First Submitted: September 30, 2014
Results First Posted: October 8, 2014
Last Update Posted: October 17, 2016