Prodromal SchizophreniaNCT00169949
Aripiprazole Treatment of the Prodrome
A study testing aripiprazole in people with Prodromal Schizophrenia and Prodromal Psychosis, run by Northwell Health at 1 site in United States.
Trial summary
The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Prodromal Schizophrenia, Prodromal Psychosis
- What is being tested?
- aripiprazole
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2006
- Phase
- Interventional
- 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 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- You are between the ages of 13 and 22.
- You are English-speaking.
- You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
- OR -
- You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- You meet additional RAP criteria assessed during screening and interview.
Who cannot join
- You have a diagnosis of bipolar disorder or major depression with psychotic features.
- You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- You have past or current substance dependence.
- You are currently taking Aripiprazole.
- You have taken Aripiprazole in the past.
- You are currently taking and responding well to another medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Official title: Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.
Read the detailed description
During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.
- Conditions
- Prodromal Schizophrenia, Prodromal Psychosis
- Being tested
- aripiprazole
- Keywords
- early intervention, social functioning, role functioning, cognition
- Medical subject headings
- Schizotypal Personality Disorder, Social Adjustment
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.
Score on attenuated positive symptom scale at 12 weeks
Score on attenuated negative symptom scale at 12 weeks
Score on adverse events rating scale at 12 weeks
Secondary outcomes (3)
Score on social functioning scale at 12 weeks
Score on academic functioning scale at 12 weeks
Score on cognitive measures at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMay 2006
Why it stopped: The study was terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Barbara Cornblatt, PhD, Principal investigator, LIJMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169949
- Sponsor's protocol ID
- 03-134
- Other IDs
- 03-134
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
- ClinicalTrials.gov ID
- NCT00169949
- Acronym / sponsor ID
- 03-134
- Conditions
- Prodromal Schizophrenia, Prodromal Psychosis
- Keywords
- early intervention, social functioning, role functioning, cognition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low enrollment.
- Enrolment
- 30 participants
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2004
- Study completion
- May 2006 (actual)
- First posted
- 15 Sep 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.
The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.
Detailed description
During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- You are between the ages of 13 and 22.
- You are English-speaking.
- You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
- OR -
- You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
Key exclusion criteria (6 listed)
- You have a diagnosis of bipolar disorder or major depression with psychotic features.
- You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- You have past or current substance dependence.
- You are currently taking Aripiprazole.
- You have taken Aripiprazole in the past.
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
Score on attenuated positive symptom scale at 12 weeks
Score on attenuated negative symptom scale at 12 weeks
Score on adverse events rating scale at 12 weeks
3 secondary outcomes
Score on social functioning scale at 12 weeks
Score on academic functioning scale at 12 weeks
Score on cognitive measures at 12 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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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.
Barbara Cornblatt, PhD principal investigator
LIJMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aripiprazole in people with Prodromal Schizophrenia and Prodromal Psychosis, run by Northwell Health at 1 site 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to low enrollment.). Results are not available in the source record.
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?
Score on attenuated positive symptom scale at 12 weeks. The study lists 3 primary outcomes in all. 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 25 Sep 2009.