Geodon for the Treatment of Refractory Social Anxiety Disorder
SAD
Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
2 other identifiers
interventional
51
1 country
2
Brief Summary
The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2004
Longer than P75 for phase_2
2 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
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 24, 2013
CompletedOctober 31, 2014
April 1, 2013
4.1 years
September 20, 2005
December 13, 2012
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Social Phobia Scale(BSPS)
An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.
Baseline, 8 and 16 weeks
Study Arms (3)
Open Label Treatment
OTHER8 weeks of open label treatment with sertraline
Randomization Ziprasidone
OTHER8 weeks of treatment with sertraline augmented with ziprasidone
Randomization Placebo
OTHER8 weeks of treatment with sertraline augmented by placebo
Interventions
Sertraline augmentation with ziprasidone
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Eligibility Criteria
You may qualify if:
- adults 18-65 years of age
- primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
- minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
- minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
- written informed consent
- negative serum pregnancy test for women of childbearing potential
- normal EKG
You may not qualify if:
- current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
- any current primary anxiety disorder other than SAD
- current primary depression
- history of substance abuse or dependence within the last 3 months
- suicide risk or serious suicide attempt within the last year
- clinically significant medical condition or laboratory or EKG abnormality
- women of childbearing potential who are unwilling to practice an acceptable method of contraception
- patients needing concurrent use of psychotropic medications
- history of hypersensitivity to sertraline or ziprasidone
- recent (less than 2 months) initiation of psychotherapy for SAD
- history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
- patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Pfizercollaborator
Study Sites (2)
Duke University Medical Center
Durham, North Carolina, 27701, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Davidson JR, Potts NL, Richichi EA, Ford SM, Krishnan KR, Smith RD, Wilson W. The Brief Social Phobia Scale. J Clin Psychiatry. 1991 Nov;52 Suppl:48-51. doi: 10.1037/t07672-000.
PMID: 1757457BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wei Zhang, MD
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Zhang, M.D.
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
September 20, 2005
First Posted
September 22, 2005
Study Start
November 1, 2004
Primary Completion
December 1, 2008
Study Completion
July 1, 2009
Last Updated
October 31, 2014
Results First Posted
May 24, 2013
Record last verified: 2013-04