12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
NCT01316302
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | 12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder | |||
Official Title ICMJE | A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder | |||
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). | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Social Anxiety Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 63 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | December 2012 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01316302 | |||
Other Study ID Numbers ICMJE | PF2010SAD WS1228302 ( Other Grant/Funding Number: Pfizer, Inc. ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | The Medical Research Network | |||
Study Sponsor ICMJE | The Medical Research Network | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | The Medical Research Network | |||
Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |