Clinical High Risk for PsychosisEarly Phase 1NCT02047539
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
A Early Phase 1 study testing Aspirin in people with Clinical High Risk for Psychosis, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2021
- Phase
- Early Phase 1
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19 - 35
- Must have a SIPS interview
- CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS
- Must demonstrate adequate decisional capacity
Who cannot join
- Under age of 19
- Have pre-existing gastrointestinal disease, heart disease
- Have kidney disease
- Taking non-steroidal anti-inflammatory medications
- Hypersensitive to NSAID (non-steroidal anti-inflammatory medications)
- Have coexisting unstable major medical illness
Show all 11Show fewer
- Are pregnant or breastfeeding
- Consume more than 2 drinks of alcohol per day
- Have a blood clotting disorder
- Are taking ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, oral hypoglycemic or uricosuric agents
- Have a history of substance abuse in past three moths or dependence in past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.
Read the detailed description
Patients will be randomly assigned to either active treatment (aspirin) or placebo.
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Aspirin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
1000 mg/day of aspirin 1000 mg/day of sugar pill
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1000 mg/day aspirin | Experimental | 1000 mg/day aspirin Receives: Drug: Aspirin |
| sugar pill | Placebo comparator | sugar pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Measured: 2 weeks
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Measured: 4 weeks
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Measured: 8 weeks
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for PsychosisStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT02047539
- Sponsor's protocol ID
- 1401013288
- Status last verified
- May 2021
- First submitted
- 24 Jan 2014
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
- ClinicalTrials.gov ID
- NCT02047539
- Acronym / sponsor ID
- 1401013288
- Conditions
- Clinical High Risk for Psychosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 28 Jan 2014 (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 primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.
Detailed description
Patients will be randomly assigned to either active treatment (aspirin) or placebo.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1000 mg/day aspirin | Experimental | Drug: Aspirin1000 mg/day aspirin |
| sugar pill | Placebo comparator | Drug: Placebosugar pill |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 19 - 35
- Must have a SIPS interview
- CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS
- Must demonstrate adequate decisional capacity
Key exclusion criteria (11 listed)
- Under age of 19
- Have pre-existing gastrointestinal disease, heart disease
- Have kidney disease
- Taking non-steroidal anti-inflammatory medications
- Hypersensitive to NSAID (non-steroidal anti-inflammatory medications)
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 |
|---|---|---|
| Aspirin1000 mg/day of aspirin 1000 mg/day of sugar pill | Drug | 1000 mg/day aspirin |
| Placebo | Drug | sugar pill |
Primary outcome
Scale of Prodromal Symptoms (SOPS)
Time frame: 2 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Time frame: 4 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Time frame: 8 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Time frame: 12 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin in people with Clinical High Risk for Psychosis, run by Yale University 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 4 inclusion and 11 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 17 May 2021. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early. 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?
Scale of Prodromal Symptoms (SOPS) (time frame: 2 weeks). The study lists 4 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 17 May 2021.