Social Anxiety DisorderPhase 4NCT01316302

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

A Phase 4 study testing Pristiq in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Social Anxiety Disorder
What is being tested?: Pristiq
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Dec 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Medical Research Network, LLC
New York, New York, 10128

Other trials in United States

About this study

Official title: A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder

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

Read the 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.

Conditions: Social Anxiety Disorder
Being tested: Pristiq, Placebo
Keywords: Social Anxiety Disorder, Social Phobia, SAD
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PristiqDrug
Also called desvenlafaxine
Flexible dose, 50-100mg QD, for 12 weeks.
PlaceboDrug
Matching placebo, taken QD for 12 weeks.

Study groups in NCT01316302
Study group	Role	What they receive
Pristiq	Experimental	Flexible dose, 50-100mg QD Receives: Drug: Pristiq
Placebo	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to study endpoint (Week 12)

Secondary outcomes (2)

Clinical Global Impression of Improvement Scale (CGI-I)
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.
Measured: Baseline to Week 12
Patient Global Impression of Change
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.
Measured: Baseline to study endpoint (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2012

First posted16 Mar 2011 (estimated)
Study startApr 2011
Primary completionNov 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01316302
Sponsor's protocol ID: PF2010SAD
Other IDs: WS1228302
Status last verified: Aug 2016
First submitted: 14 Mar 2011
Last updated: 17 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder
ClinicalTrials.gov ID: NCT01316302
Acronym / sponsor ID: PF2010SAD
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder, Social Phobia, SAD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: The Medical Research NetworkUniversity, hospital or other
Collaborators: Pfizer
Study start: Apr 2011
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 16 Mar 2011 (estimated)
Results: Posted 8 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pristiq	Experimental	Drug: PristiqFlexible dose, 50-100mg QD
Placebo	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PristiqAlso: desvenlafaxineFlexible dose, 50-100mg QD, for 12 weeks.	Drug	Pristiq
PlaceboMatching placebo, taken QD for 12 weeks.	Drug	Placebo

Primary outcome

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.

2 secondary outcomes

Clinical Global Impression of Improvement Scale (CGI-I)
Time frame: Baseline to Week 12
Patient Global Impression of Change
Time frame: Baseline to study endpoint (Week 12)

Results and safety

Results posted to the registry on 8 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pristiq	30	20
Placebo	33	22

Primary outcome: Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score

Time frame: Baseline to study endpoint (Week 12). Mean (Standard Deviation). Unit: Scores on a scale

Measure	Pristiq n = 29	Placebo n = 29
Mean baseline LSAS total	93.4 (17.1)	92.1 (16.8)
Endpoint LSAS total	55.0 (27.4)	63.4 (22.1)
Mean LSAS change from baseline	38.4 (28.8)	28.7 (24.2)

Population analysed: The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 weeks. Other adverse events reported at .06% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pristiq	0 of 30 (0%)	26 of 30 (86.7%)	Not reported
Placebo	0 of 33 (0%)	25 of 33 (75.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about The Medical Research Network.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael R. Liebowitz, MD principal investigator

The Medical Research Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pristiq in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score (time frame: Baseline to study endpoint (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.