Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder
Improving Outcomes in Pharmacotherapy of Social Phobia
3 other identifiers
interventional
397
2 countries
3
Brief Summary
This study will compare the effectiveness of either adding clonazepam or placebo to standard treatment or switching to venlafaxine in treating generalized social anxiety disorder in individuals who have not responded to treatment with sertraline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedOctober 14, 2013
August 1, 2013
5.8 years
January 25, 2006
April 22, 2013
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders
The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Measured at Week 22 (Endpoint)
Secondary Outcomes (1)
Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores
Change from Week 10 to Week 22
Study Arms (3)
Sertraline & Clonazepam
EXPERIMENTALPhase I non-responders randomized to this group remained on sertraline at the same dose level as at entry into Phase 2 with the addition of clonazepam up to 3.0mg per day. Dosing was flexible, permitting clinicians to slow or suspend the titration of the medication because of side effects or response, but patients had to receive no less than 0.5mg of clonazepam per day in order to remain in the study.
Venlafaxine
EXPERIMENTALPhase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg per day. Dosing was flexible, permitting clinicians to slow or suspend the titration of the medication because of side effects or response, but patients had to receive no less than 75 mg venlafaxine per day in order to remain in the study.
Sertraline & Placebo
EXPERIMENTALPhase I non-responders randomized to this group remained on sertraline at the same dose level as at entry into Phase 2 with the addition of placebo. Dosing was flexible, permitting clinicians to slow or suspend the titration of the medication because of side effects or response, but patients had to receive no less than 1 capsule of placebo per day in order to remain in the study.
Interventions
Eligibility Criteria
You may qualify if:
- Primary psychiatric diagnosis of GSAD as defined by DSM-IV criteria and a score above 60 on the LSAS
- Agrees to use an effective form of contraception throughout the study
You may not qualify if:
- Clinically significant abnormalities found upon physical examination, electrocardiogram, and laboratory tests
- History of more than two unsuccessful, adequate treatment trials, indicated by a lack of response to over 10 weeks of any of the following: SSRIs (e.g., 40 mg of paroxetine or its equivalent per day); benzodiazepine (e.g. at least 2.5 mg of clonazepam per day) plus antidepressant (adequate dose as above); monoamine oxidase inhibitors (e.g., 60 mg of phenelzine or its equivalent per day); or a single failed trial of over 10 weeks of venlafaxine ( at least 150 mg per day)
- Pregnant or breastfeeding
- Simultaneous use of other psychotropic medications, with the exception of psychostimulants to treat ADHD; participants must discontinue regular benzodiazepine or antidepressant therapy at least two weeks (5 weeks for fluoxetine) prior to study entry; beta-blockers must be discontinued unless they are indicated medically (e.g., for hypertension)
- DSM-IV diagnosis of any of the following: lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorder, bipolar disorder, or obsessive compulsive disorder; eating disorder in the past 6 months; alcohol or substance abuse in the past 3 months or dependence within the past 6 months (entry of participants with major depression, dysthymia, panic disorder, generalized anxiety disorder, or post-traumatic stress disorder will be permitted if the social anxiety disorder is judged to be the predominant disorder)
- Significant suicidal ideation as indicated by a score greater than 3 on the Montgomery-Asberg Depression Rating Scale or suicidal behaviors within 6 months prior to study entry
- Significant personality dysfunction that could interfere with study participation
- Serious medical illness or instability for which hospitalization may be likely during the study
- Seizure disorders, with the exception of a childhood history of isolated, non-recurrent febrile seizures
- Any concurrent psychotherapy initiated within 3 months of study entry, or ongoing psychotherapy of any duration directed specifically toward treatment of GSAD (prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic therapy that focuses on exploring specific, dynamic causes of the phobic symptomatology and that provides management skills; general supportive therapy for more than 3 months is acceptable)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California San Diego
La Jolla, California, 92093, United States
Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, 02116, United States
McMaster University Medical Centre Anxiety Disorders Clinic
Hamilton, Ontario, L8N 3Z5, Canada
Related Publications (1)
Pollack MH, Van Ameringen M, Simon NM, Worthington JW, Hoge EA, Keshaviah A, Stein MB. A double-blind randomized controlled trial of augmentation and switch strategies for refractory social anxiety disorder. Am J Psychiatry. 2014 Jan;171(1):44-53. doi: 10.1176/appi.ajp.2013.12101353.
PMID: 24399428DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Pollack, M.D.
- Organization
- Rush University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mark H. Pollack, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Murray B. Stein, MD, MPH
University of California San Deigo
- PRINCIPAL INVESTIGATOR
Michael Van Ameringen, MD, FRCPC
Anxiety Disorders Clinic McMaster University Medical Centre
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 14, 2013
Results First Posted
October 14, 2013
Record last verified: 2013-08