SchizophreniaPhase 2/3NCT00237874
Aripiprazole Treatment of Prodromal Patients
A Phase 2/3 study testing Aripiprazole in people with Schizophrenia and Psychosis, run by Yale University at 2 sites in United States.
Trial summary
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Aripiprazole
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2004to Feb 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 13 to 40 meet criteria for the prodrome for schizophrenia
Who cannot join
- history of psychosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Living
Hartford, Connecticut, 06106
Yale School of Medicine
New Haven, Connecticut, 06512
About this study
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.
Read the detailed description
This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Aripiprazole
- Keywords
- prodrome, ultra high risk, aripiprazole
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score of the Scale Of Prodromal Symptoms
This is a 19-item scale with items scores 0-6. Treatment response is defined as all 5 Scale of Prodromal Syndromes positive symtpom items being rate below the prodromal range (< or equal to 2).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startFeb 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Scott W Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237874
- Sponsor's protocol ID
- YaleHIC26037
- Status last verified
- Jun 2014
- First submitted
- 7 Oct 2005
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole Treatment of Prodromal Patients
- ClinicalTrials.gov ID
- NCT00237874
- Acronym / sponsor ID
- YaleHIC26037
- Conditions
- Schizophrenia, Psychosis
- Keywords
- prodrome, ultra high risk, aripiprazole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.
Detailed description
This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- age 13 to 40 meet criteria for the prodrome for schizophrenia
Key exclusion criteria (1 listed)
- history of psychosis
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Total Score of the Scale Of Prodromal Symptoms
Time frame: 8 weeks
This is a 19-item scale with items scores 0-6. Treatment response is defined as all 5 Scale of Prodromal Syndromes positive symtpom items being rate below the prodromal range (< or equal to 2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aripiprazole in people with Schizophrenia and Psychosis, run by Yale University at 2 sites in United States.
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 1 inclusion and 1 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Score of the Scale Of Prodromal Symptoms (time frame: 8 weeks). 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 6 Jun 2014.