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

• 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: The Medical Research Network
• Collaborator: Pfizer
• Information provided by (Responsible Party): The Medical Research Network

Study Description

Brief Summary:

This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Drug: Pristiq; Drug: Placebo	Phase 4

Detailed Description:

Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pristiq; Flexible dose, 50-100mg QD	Drug: Pristiq; Flexible dose, 50-100mg QD, for 12 weeks.; Other Name: desvenlafaxine
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Matching placebo, taken QD for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, New York

The Medical Research Network, LLC

New York, New York, United States, 10128

Sponsors and Collaborators

The Medical Research Network

Pfizer

Investigators

• Principal Investigator: Michael R. Liebowitz, MD; The Medical Research Network

More Information

Additional Information:

Click here for more information about The Medical Research Network. 

• Responsible Party: The Medical Research Network
• ClinicalTrials.gov Identifier: NCT01316302
• Other Study ID Numbers: PF2010SAD; WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. )
• First Posted: March 16, 2011
• Results First Posted: October 8, 2014
• Last Update Posted: October 17, 2016
• Last Verified: August 2016

Keywords provided by The Medical Research Network:

Social Anxiety Disorder; Social Phobia; SAD

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Phobia, Social; Pathologic Processes; Mental Disorders; Phobic Disorders; Desvenlafaxine Succinate; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Antidepressive Agents; Psychotropic Drugs