Social Anxiety DisorderPhase 2SADNCT00215150
Geodon for the Treatment of Refractory Social Anxiety Disorder
A Phase 2 study testing Ziprasidone and Sertraline in people with Social Anxiety Disorder, run by Duke University at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Ziprasidone and Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Jul 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27701
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
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
Read the detailed description
This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.
- Conditions
- Social Anxiety Disorder
- Being tested
- Ziprasidone, Sertraline
- Keywords
- anxiety disorder, SAD, ziprasidone, sertraline, antidepressant, antipsychotic
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
Also called Geodon
Sertraline augmentation with ziprasidone
SertralineDrug
Also called Zoloft
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment | Other | 8 weeks of open label treatment with sertraline Receives: Drug: Sertraline |
| Randomization Ziprasidone | Other | 8 weeks of treatment with sertraline augmented with ziprasidone Receives: Drug: Ziprasidone; Drug: Sertraline |
| Randomization Placebo | Other | 8 weeks of treatment with sertraline augmented by placebo Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2008
- Study completionJul 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215150
- Sponsor's protocol ID
- Pro00012882
- Other IDs
- 6479
- Acronym
- SAD
- Status last verified
- Apr 2013
- First submitted
- 20 Sep 2005
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 1757457
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00215150
- Acronym / sponsor ID
- SAD / Pro00012882
- Conditions
- Social Anxiety Disorder
- Keywords
- anxiety disorder, SAD, ziprasidone, sertraline, antidepressant, antipsychotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment | Other | Drug: Sertraline8 weeks of open label treatment with sertraline |
| Randomization Ziprasidone | Other | Drug: Ziprasidone, Drug: Sertraline8 weeks of treatment with sertraline augmented with ziprasidone |
| Randomization Placebo | Other | Drug: Sertraline8 weeks of treatment with sertraline augmented by placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| ZiprasidoneAlso: GeodonSertraline augmentation with ziprasidone | Drug | Randomization Ziprasidone |
| SertralineAlso: ZoloftTreatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase | Drug | Open Label Treatment, Randomization Placebo, Randomization Ziprasidone |
Primary outcome
Brief Social Phobia Scale(BSPS)
Time frame: Baseline, 8 and 16 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1757457Davidson 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.
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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.
Wei Zhang, M.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ziprasidone and Sertraline in people with Social Anxiety Disorder, run by Duke University at 2 sites 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 7 inclusion and 12 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 May 2013). 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?
Brief Social Phobia Scale(BSPS) (time frame: Baseline, 8 and 16 weeks). 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 NCT00215150, which also lists 1 linked publication.
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 31 Oct 2014.