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
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|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Drug: Pristiq Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
Flexible dose, 50-100mg QD
Flexible dose, 50-100mg QD, for 12 weeks.
Other Name: desvenlafaxine
Placebo Comparator: Placebo
Matching placebo, taken QD for 12 weeks.
- Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score [ Time Frame: Baseline to study endpoint (Week 12) ]Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
- Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Baseline to Week 12 ]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.
- Patient Global Impression of Change [ Time Frame: Baseline to study endpoint (Week 12) ]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.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects must give written informed consent prior to any study procedures.
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.
- A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
- A total HAM-D score of less than 15 at the Screening visit.
- CGI Severity score of 4 or greater at both Screening and Baseline visits.
- Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.
- An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.
- Any history or complication of schizophrenia or bipolar disorder.
- Any complication of body dysmorphic disorder.
- Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
- Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
- Subjects scoring >2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
- Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95.
- Positive Urine Drug Screen at the Screening visit.
- Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
- Any history or complication of cancer or malignant tumor.
- Fluoxetine within 28 days of Baseline
- MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week.
- Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.
- Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
- Treatment refractory GSAD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316302
|United States, New York|
|The Medical Research Network, LLC|
|New York, New York, United States, 10128|
|Principal Investigator:||Michael R. Liebowitz, MD||The Medical Research Network|
|Responsible Party:||The Medical Research Network|
|Other Study ID Numbers:||
WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
|First Posted:||March 16, 2011 Key Record Dates|
|Results First Posted:||October 8, 2014|
|Last Update Posted:||October 17, 2016|
|Last Verified:||August 2016|
Social Anxiety Disorder
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Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs