Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00114127
First received: June 13, 2005
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: January 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Anxiety Disorder
Interventions: Drug: Duloxetine
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
Treatment seeking outpatients aged 18 years and older with a primary diagnosis of Generalized Social Anxiety Disorder (GSAD) were recruited by media advertisement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Of the 39 participants who completed Phase I of this study, 28 moved on to Phase II.

1 subject was lost to follow up between baseline and week 1.


Reporting Groups
  Description
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
Duloxetine 120mg/Day for 18 Weeks (Phase 2) Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.

Participant Flow:   Overall Study
    Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)     Duloxetine 120mg/Day for 18 Weeks (Phase 2)  
STARTED     13     15  
COMPLETED     9     11  
NOT COMPLETED     4     4  
Adverse Event                 2                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 3  



  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
Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2) Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
Duloxetine 120mg/Day for 18 Weeks (Phase 2) Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
Total Total of all reporting groups

Baseline Measures
    Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)     Duloxetine 120mg/Day for 18 Weeks (Phase 2)     Total  
Number of Participants  
[units: participants]
  13     15     28  
Age, Customized  
[units: Years]
Mean ± Standard Deviation
     
Age Baseline     36.6  ± 14.2     35.5  ± 11.6     36  ± 12.6  
Gender, Customized  
[units: Participants]
     
Female     7     4     11  
Male     6     11     17  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     9     13     22  
Asian     1     1     2  
Black     1     1     2  
Alaskan Native     1     0     1  
Native Hawaiian or Pacific Islander     1     0     1  
Educational status, college graduate  
[units: Participants]
     
College Graduate     10     7     17  
Not College Graduate     3     8     11  
Duration of illness, mean years (SD)  
[units: Years]
Mean ± Standard Deviation
  27.6  ± 17.0     20.1  ± 12.3     23.7  ± 14.9  
Age of onset, mean age  
[units: Years]
Mean ± Standard Deviation
  9.9  ± 3.3     13.9  ± 8.1     12.0  ± 6.46  
Current comorbidity, Major depressive disorder (MDD)  
[units: Participants]
     
Comorbid MDD     5     0     5  
No Comorbid MDD     8     15     23  
Current comorbidity, Dysthymia  
[units: Participants]
     
Comorbid Dysthymia     2     0     2  
No Comorbid Dysthymia     11     15     26  
Current comorbidity, Panic Disorder (PD)  
[units: Participants]
     
Comorbid PD     1     0     1  
No Comorbid PD     12     15     27  
Current comorbidity, Generalized anxiety disorder (GAD)  
[units: Participants]
     
Comorbid GAD     2     0     2  
No Comorbid GAD     11     15     26  
At least one concurrent mood or anxiety disorder  
[units: Participants]
     
Concurrent mood or anxiety disorder     7     1     8  
No concurrent mood or anxiety disorders     6     14     20  
Lifetime depression  
[units: Participants]
     
Lifetime depression     6     4     10  
No Lifetime depression     7     11     18  
Lifetime alcohol or substance abuse or dependence  
[units: Participants]
     
Lifetime Alcohol/substance abuse/dependence     3     3     6  
No Lifetime Alcohol/substance abuse/dependence     10     12     22  
Liebowitz Social Anxiety Scale (LSAS) [1]
[units: LSAS Score]
Mean ± Standard Deviation
  75.2  ± 6.90     74.1  ± 6.20     74.6  ± 4.52  
Clinical Global Impression-Severity (CGI-S) [2]
[units: CGI-S Score]
Mean ± Standard Deviation
  5.10  ± 0.43     4.93  ± 0.36     5.00  ± 0.27  
Clinical Global Impression-Improvement (CGI-I) [3]
[units: CGI-I Score]
Mean ± Standard Deviation
  3.25  ± 0.97     3.36  ± 1.22     3.31  ± 1.09  
Montgomery Asberg Depression Rating Scale (MADRS) [4]
[units: MADRS Score]
Mean ± Standard Deviation
  8.08  ± 5.00     10.3  ± 7.79     9.17  ± 6.60  
Sheehan Disability Scale (SDS) [5]
[units: SDS Score]
Mean ± Standard Deviation
  11.2  ± 6.06     14.1  ± 5.52     12.9  ± 5.71  
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [6]
[units: Q-LES-Q Score]
Mean ± Standard Deviation
  49.1  ± 8.83     46.2  ± 9.47     47.5  ± 9.12  
Liebowitz Self-Rated Disability Scale (LSDSR) [7]
[units: LSDSR Score]
Mean ± Standard Deviation
  7.58  ± 6.43     10.0  ± 5.41     8.79  ± 5.83  
[1]

The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety (55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia). It is widely used in treatment studies of SAD. The instrument shows very good psychometric properties (Heimberg et al., 1999; Safren et al., 1999).

Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6.

[2]

The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6.

[3]

The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global improvement of symptoms (Guy, 1976). The CGI ranges from 1 (very much improved) to 7 (very much worse).

Baseline CGI-I was not collected in Phase 1 as it is a measure of improvement. Baseline CGI-I was collected in Phase 2 because patients were transitioning from week 6 to 7.

[4]

MADRS; Montgomery & Asberg, 1979. The MADRS is designed to measure the overall severity of depressive symptoms and has demonstrated good reliability and sensitivity to change with treatment. It includes 10 items and uses a 0-6 severity scale with higher scores indicating increasing depressive symptoms. Ratings can be added to form an overall score (range 0 to 60); no weights are used. Cut-off points include: 0 to 6 – symptom absent, 7 to 19 – mild depression, 30 to 34 – moderate, 35 to 60 – severe depression.

Baseline MADRS only collected in Phase 2 at week 6.

[5]

The SDS is a brief self-report questionnaire that was developed to assess functional impairment in three inter-related domains; work/school, social and family life. The patient rates the extent to which work/school, social and family responsibilities are impaired by his/her symptoms on a 10 point visual analog scale. The three items are summed into a single dimension measure of global function impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

Baseline SDS only collected in Phase 2 at week 6.

[6]

Q-LES-Q; Endicott et al., 1993. This questionnaire rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70, with higher scores indicating higher satisfaction with quality of life.

Baseline QLESQ only collected in Phase 2 at week 6.

[7]

The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.

Baseline was only collected for Phase 2 at week 6




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale   [ Time Frame: 6 months ]

2.  Secondary:   CGI-S   [ Time Frame: 6 months ]


  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
Open-label in phase Phase 1; Limited power due to small sample size.


  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: Dr. Naomi Simon
Organization: Massachusetts General Hospital
phone: 617-726-7913
e-mail: nsimon@partners.org


No publications provided


Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00114127     History of Changes
Other Study ID Numbers: 2004-P-001384
Study First Received: June 13, 2005
Results First Received: January 27, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board