Psychosis Prodrome
Conditions
Keywords
psychosis, schizophrenia, prodrome, ziprasidone, placebo
Brief summary
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
Interventions
DRUGziprasidone
20-160 mg/d
DRUGplacebo
placebo
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis * clinically referred
Exclusion criteria
* prolonged corrected QT interval * history of syncope
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to Psychosis | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scale of Psychosis-risk Symptoms Total Score | baseline and 8 weeks | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ziprasidone ziprasidone: 20-160 mg/d | 23 |
| Placebo placebo: placebo | 27 |
| Total | 50 |
Baseline characteristics
| Characteristic | Ziprasidone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 4.7 | 22.6 years STANDARD_DEVIATION 3.7 | 22.3 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment United States | 23 participants | 27 participants | 50 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 19 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 24 | 2 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 27 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ziprasidone | Conversion to Psychosis | 1 participants |
| Placebo | Conversion to Psychosis | 2 participants |
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.
Time frame: baseline and 8 weeks
Population: All subjects who received allocated intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ziprasidone | Change in Scale of Psychosis-risk Symptoms Total Score | -0.271 scores on a scale |
| Placebo | Change in Scale of Psychosis-risk Symptoms Total Score | 0 scores on a scale |