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Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00282828
Recruitment Status : Completed
First Posted : January 27, 2006
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Social Phobia
Interventions Drug: Sertraline
Drug: Venlafaxine
Drug: Placebo
Drug: Clonazepam
Enrollment 397
Recruitment Details Recruitment for this study began in 2006 at the Massachusetts General Hospital, the University of California San Diego, and the Anxiety Disorders Clinic, McMaster University Medical Centre. Through approved recruitment methods, 397 patients with Generalized Social Anxiety Disorder (GSAD) were enrolled in Phase I of the study (open sertraline).
Pre-assignment Details Among the 397 patients enrolled in Phase I of the study, 295 patients entered Phase II. A total of 181 (61%) of the patients who began Phase II were non-responders at week 10 (LSAS>50), and were therefore randomized to receive 12 weeks of treatment in one of three treatment arms (sertraline plus clonazepam, venlafaxine, or sertraline plus placebo).
Arm/Group Title Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Hide Arm/Group Description Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d. Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d. Phase I non-responders randomized to this group received prolonged sertraline and placebo.
Period Title: Overall Study
Started 63 59 59
Completed 57 47 50
Not Completed 6 12 9
Arm/Group Title Sertraline and Clonazepam Venlafaxine Sertraline and Placebo Total
Hide Arm/Group Description Participants will take both sertraline and clonazepam Participants will take venlafaxine only Participants will take both sertraline and placebo Total of all reporting groups
Overall Number of Baseline Participants 63 59 59 181
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 59 participants 59 participants 181 participants
34.7  (12.2) 33.7  (12.0) 35.3  (14.2) 34.6  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 59 participants 59 participants 181 participants
Female
25
  39.7%
21
  35.6%
20
  33.9%
66
  36.5%
Male
38
  60.3%
38
  64.4%
39
  66.1%
115
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 59 participants 59 participants 181 participants
United States 37 34 34 105
Canada 26 25 25 76
1.Primary Outcome
Title Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders
Hide Description The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Time Frame Measured at Week 22 (Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.
Arm/Group Title Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Hide Arm/Group Description:
Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
Phase I non-responders randomized to this group received prolonged sertraline and placebo.
Overall Number of Participants Analyzed 63 59 59
Measure Type: Number
Unit of Measure: participants
17 11 10
2.Secondary Outcome
Title Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores
Hide Description The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Time Frame Change from Week 10 to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.
Arm/Group Title Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Hide Arm/Group Description:
Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
Phase I non-responders randomized to this group received prolonged sertraline and placebo.
Overall Number of Participants Analyzed 63 59 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
27  (24.4) 18  (19) 16  (23)
Time Frame Phase II, consisting of 12 weeks of randomized treatment.
Adverse Event Reporting Description Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
 
Arm/Group Title Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Hide Arm/Group Description Participants will take both sertraline and clonazepam Participants will take venlafaxine only Participants will take both sertraline and placebo
All-Cause Mortality
Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/63 (4.76%)      0/59 (0.00%)      0/59 (0.00%)    
General disorders       
Shortness of Breath   1/63 (1.59%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
Panic Attack   1/63 (1.59%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
Pacemaker inserted   1/63 (1.59%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline and Clonazepam Venlafaxine Sertraline and Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/63 (80.95%)      51/59 (86.44%)      55/59 (93.22%)    
General disorders       
ASTHENIA   11/63 (17.46%)  14 8/59 (13.56%)  10 15/59 (25.42%)  16
HEADACHE   12/63 (19.05%)  14 8/59 (13.56%)  11 15/59 (25.42%)  28
ANOREXIA   8/63 (12.70%)  9 11/59 (18.64%)  11 8/59 (13.56%)  9
DRY MOUTH   8/63 (12.70%)  8 12/59 (20.34%)  12 8/59 (13.56%)  8
INSOMNIA   8/63 (12.70%)  10 21/59 (35.59%)  27 25/59 (42.37%)  31
LIBIDO DECREASED   9/63 (14.29%)  9 6/59 (10.17%)  6 14/59 (23.73%)  15
SOMNOLENCE   20/63 (31.75%)  26 9/59 (15.25%)  11 14/59 (23.73%)  18
ABNORMAL DREAMS   6/63 (9.52%)  6 9/59 (15.25%)  9 11/59 (18.64%)  11
ABNORMAL EJACULATION   7/63 (11.11%)  8 6/59 (10.17%)  6 3/59 (5.08%)  3
AMNESIA   1/63 (1.59%)  1 3/59 (5.08%)  3 1/59 (1.69%)  1
ANXIETY   3/63 (4.76%)  3 1/59 (1.69%)  1 3/59 (5.08%)  3
CONSTIPATION   1/63 (1.59%)  1 6/59 (10.17%)  8 4/59 (6.78%)  5
COUGH INCREASED   2/63 (3.17%)  2 0/59 (0.00%)  0 3/59 (5.08%)  3
DEPRESSION   2/63 (3.17%)  2 4/59 (6.78%)  4 2/59 (3.39%)  2
DIARRHEA   7/63 (11.11%)  8 5/59 (8.47%)  5 11/59 (18.64%)  14
DIZZINESS   6/63 (9.52%)  6 7/59 (11.86%)  7 6/59 (10.17%)  6
DYSPEPSIA   3/63 (4.76%)  3 1/59 (1.69%)  1 5/59 (8.47%)  8
INCREASED APPETITE   2/63 (3.17%)  2 1/59 (1.69%)  1 4/59 (6.78%)  4
INFECTION   4/63 (6.35%)  5 5/59 (8.47%)  5 3/59 (5.08%)  3
NAUSEA   8/63 (12.70%)  8 7/59 (11.86%)  7 9/59 (15.25%)  11
NERVOUSNESS   4/63 (6.35%)  5 9/59 (15.25%)  11 10/59 (16.95%)  14
PAIN   2/63 (3.17%)  2 1/59 (1.69%)  1 5/59 (8.47%)  5
PHARYNGITIS   4/63 (6.35%)  4 3/59 (5.08%)  3 3/59 (5.08%)  4
RASH   1/63 (1.59%)  1 2/59 (3.39%)  2 3/59 (5.08%)  3
SEXUAL FUNCTION ABNORMAL   8/63 (12.70%)  8 6/59 (10.17%)  7 12/59 (20.34%)  14
SWEATING   1/63 (1.59%)  1 8/59 (13.56%)  8 10/59 (16.95%)  10
THINKING ABNORMAL   3/63 (4.76%)  3 2/59 (3.39%)  2 4/59 (6.78%)  4
TOOTH DISORDER   2/63 (3.17%)  2 5/59 (8.47%)  5 6/59 (10.17%)  7
TREMOR   6/63 (9.52%)  6 6/59 (10.17%)  6 2/59 (3.39%)  2
TWITCHING   1/63 (1.59%)  1 2/59 (3.39%)  2 4/59 (6.78%)  4
URINARY FREQUENCY   0/63 (0.00%)  0 1/59 (1.69%)  1 4/59 (6.78%)  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: Mark Pollack, M.D.
Organization: Rush University Medical Center
Phone: 312-942-5372
EMail: mark_pollack@rush.edu
Layout table for additonal information
Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00282828     History of Changes
Other Study ID Numbers: R01MH070919 ( U.S. NIH Grant/Contract )
R01MH070919 ( U.S. NIH Grant/Contract )
PA-01-123
DSIR 83-ATAS
First Submitted: January 25, 2006
First Posted: January 27, 2006
Results First Submitted: April 22, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013