Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6479 | Other Identifier | Duke legacy protocol number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Treatment | Other | 8 weeks of open label treatment with sertraline |
|
| Randomization Ziprasidone | Other | 8 weeks of treatment with sertraline augmented with ziprasidone |
|
| Randomization Placebo | Other | 8 weeks of treatment with sertraline augmented by placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | Sertraline augmentation with ziprasidone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1757457 | Background | 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. |
Not provided
Not provided
Not provided
Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Treatment | 8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Phase |
|
| ||||||||||||||||||||||||
| Randomization Phase Ziprasidone |
| |||||||||||||||||||||||||
| Randomization Phase Placebo |
|
This is the intent to treat population consisting of subjects completing at least one post baseline visit.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Treatment | 8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 and 16 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Phase | The first 8 weeks of treatment on sertraline |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang, MD | Duke University Medical Center | (919) 684 5645 | wei.zhang@duke.edu |
Not provided
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C092292 | ziprasidone |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sertraline | Drug | Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase |
|
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| Did not meet randomization criteria |
|
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Randomization Phase for Ziprasidone Group |
The group of subjects randomized to receive Ziprasidone for the second 8 weeks |
| OG002 | Randomization Phase for Placebo Group | The group of subjects randomized to receive placebo for the second 8 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Randomization Phase for Ziprasidone | The second phase of treatment with subjects randomized to ziprasidone augmentation. | 0 | 10 | 0 | 10 |
| EG002 | Randomization Phase for Placebo | The second phase of treatment with subjects randomized to placebo augmentation. | 0 | 11 | 0 | 11 |
Not provided
Not provided
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |