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

NCT01316302 | Completed Phase 4 Results

• 2 other identifiers: PF2010SADWS1228302
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder; Social Phobia; SAD

Outcome Measures

Primary Outcomes (1)

• Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score

  Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.

  Baseline to study endpoint (Week 12)

Secondary Outcomes (2)

• Clinical Global Impression of Improvement Scale (CGI-I)

  Baseline to Week 12

• Patient Global Impression of Change

  Baseline to study endpoint (Week 12)

Study Arms (2)

Pristiq

EXPERIMENTAL

Flexible dose, 50-100mg QD

Drug: Pristiq

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Pristiq DRUG

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

Also known as: desvenlafaxine

Pristiq

Placebo DRUG

Matching placebo, taken QD for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Medical Research Network: lead
• Pfizer: collaborator

Study Sites (1)

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Related Links

• Click here for more information about The Medical Research Network.

MeSH Terms

Conditions

Phobia, Social

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Results Point of Contact

• Title: Michael R. Liebowitz, M.D.
• Organization: The Medical Research Network, LLC

MLiebowitz@MedicalResearchNetwork.com

(212) 595-5012

Study Officials

• Michael R. Liebowitz, MD

  The Medical Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 16, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 17, 2016
• Results First Posted: October 8, 2014

Record last verified: 2016-08

Locations

US (1)