Psychosis ProdromePhase 2ZIPNCT00635700
Ziprasidone in the Psychosis Prodrome
A Phase 2 study testing ziprasidone in people with Psychosis Prodrome, run by Yale University at 11 sites in 2 countries.
Trial summary
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Psychosis Prodrome
- What is being tested?
- ziprasidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2008to Nov 2012
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
- clinically referred
Who cannot join
- prolonged corrected QT interval
- history of syncope
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Emory University
Atlanta, Georgia, 30322
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599
Wayne State University School of Medicine
Detroit, Michigan, 48201
North Shore, Long Island Jewish Health System
Glen Oaks, New York, 11004
University of California at San Diego
La Jolla, California, 92093
University of California at Los Angeles
Los Angeles, California, 90095
Yale University School of Medicine
New Haven, Connecticut, 06519
University of California, San Francisco
San Francisco, California, 94143
University of Massachusetts
Worcester, Massachusetts, 01604
About this study
Official title: Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
- Conditions
- Psychosis Prodrome
- Being tested
- ziprasidone, placebo
- Keywords
- psychosis, schizophrenia, prodrome, ziprasidone, placebo
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
Also called Geodon
20-160 mg/d
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | Experimental | Patients will be treated with Ziprasidone for 6 months Receives: Drug: ziprasidone |
| Placebo | Placebo comparator | Patients will be treated with placebo for 6 months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2012
- Study completionNov 2012
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.
- Other trials for Psychosis ProdromeStudies of the same condition, open and under way.
- More trials run by Yale 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott W Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635700
- Sponsor's protocol ID
- 0801003386
- Other IDs
- IIR GA1281GE
- Acronym
- ZIP
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2008
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
- ClinicalTrials.gov ID
- NCT00635700
- Acronym / sponsor ID
- ZIP / 0801003386
- Conditions
- Psychosis Prodrome
- Keywords
- psychosis, schizophrenia, prodrome, ziprasidone, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | Experimental | Drug: ziprasidonePatients will be treated with Ziprasidone for 6 months |
| Placebo | Placebo comparator | Drug: placeboPatients will be treated with placebo for 6 months |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
- clinically referred
Key exclusion criteria (2 listed)
- prolonged corrected QT interval
- history of syncope
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: Geodon20-160 mg/d | Drug | Ziprasidone |
| placeboplacebo | Drug | Placebo |
Primary outcome
Conversion to Psychosis
Time frame: 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.
1 secondary outcome
Change in Scale of Psychosis-risk Symptoms Total Score
Time frame: baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott W Woods, MD principal investigator
Yale University
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ziprasidone in people with Psychosis Prodrome, run by Yale University at 11 sites in 2 countries.
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 2 inclusion and 2 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 27 Oct 2016). 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?
Conversion to Psychosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.