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| ID | Type | Description | Link |
|---|---|---|---|
| IIR GA1281GE |
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This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziprasidone | Experimental | Patients will be treated with Ziprasidone for 6 months |
|
| Placebo | Placebo Comparator | Patients will be treated with placebo for 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone | Drug | 20-160 mg/d |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Conversion to Psychosis | Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scale of Psychosis-risk Symptoms Total Score | The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott W Woods, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | La Jolla | California | 92093 | United States | ||
| University of California at Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | ziprasidone: 20-160 mg/d |
| FG001 | Placebo | placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of 51 patients randomized, 27 were assigned to placebo and 24 to ziprasidone. One case allocated to ziprasidone was never dispensed study medication and was removed from analysis per protocol, leaving 23.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | ziprasidone: 20-160 mg/d |
| BG001 | Placebo | placebo: placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Conversion to Psychosis | Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria. | In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study's blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis. | Posted | Number | participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone | ziprasidone: 20-160 mg/d |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EKG abnormalities | Cardiac disorders | Systematic Assessment | Any emergent EKG abnormality including QTcF prolongation > 460 msec, or 15% of baseline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott W. Woods, M.D. | Yale University | 203-974-7038 | scott.woods@yale.edu |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| placebo |
| Drug |
placebo |
|
| baseline and 8 weeks |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Beth Israel Deaconess Hospital | Boston | Massachusetts | 02215 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01604 | United States |
| Wayne State University School of Medicine | Detroit | Michigan | 48201 | United States |
| North Shore, Long Island Jewish Health System | Glen Oaks | New York | 11004 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| University of Calgary | Calgary | Alberta | T2N2T9 | Canada |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo: placebo
|
|
| Secondary | Change in Scale of Psychosis-risk Symptoms Total Score | The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome. | All subjects who received allocated intervention | Posted | Mean | 95% Confidence Interval | scores on a scale | baseline and 8 weeks |
|
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| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Placebo | placebo: placebo | 0 | 27 | 2 | 27 |
|
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