Social Anxiety Disorder
Conditions
Keywords
anxiety disorder, SAD, ziprasidone, sertraline, antidepressant, antipsychotic
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
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.
Interventions
DRUGZiprasidone
Sertraline augmentation with ziprasidone
DRUGSertraline
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Sponsors
Pfizer
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Social Phobia Scale(BSPS) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.
Participants by arm
| Arm | Count |
|---|---|
| Study Treatment 8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Open Label Phase | Did not complete a post base visit | 13 |
| Open Label Phase | Did not meet randomization criteria | 9 |
| Open Label Phase | Lost to Follow-up | 7 |
| Open Label Phase | Withdrawal by Subject | 1 |
| Randomization Phase Placebo | Withdrawal by Subject | 1 |
| Randomization Phase Ziprasidone | Lost to Follow-up | 2 |
| Randomization Phase Ziprasidone | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 33.5 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 38 | 0 / 10 | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline, 8 and 16 weeks
Population: The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Phase | Brief Social Phobia Scale(BSPS) | Beginning of Study Phase | 44.0 units on a scale | Standard Deviation 11.1 |
| Open Label Phase | Brief Social Phobia Scale(BSPS) | End of Study Phase | 31.2 units on a scale | Standard Deviation 16 |
| Randomization Phase for Ziprasidone Group | Brief Social Phobia Scale(BSPS) | Beginning of Study Phase | 31.8 units on a scale | Standard Deviation 8.9 |
| Randomization Phase for Ziprasidone Group | Brief Social Phobia Scale(BSPS) | End of Study Phase | 21.0 units on a scale | Standard Deviation 13.6 |
| Randomization Phase for Placebo Group | Brief Social Phobia Scale(BSPS) | Beginning of Study Phase | 31.8 units on a scale | Standard Deviation 11.8 |
| Randomization Phase for Placebo Group | Brief Social Phobia Scale(BSPS) | End of Study Phase | 24.6 units on a scale | Standard Deviation 12.3 |
Comparison: Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.p-value: <0.001Wilcoxon Signed Rank Test
Comparison: Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.p-value: >0.05Kruskal-Wallis