ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02047539
Recruitment Status : Recruiting
First Posted : January 28, 2014
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Clinical High Risk for Psychosis Drug: Aspirin Drug: Placebo Early Phase 1

Detailed Description:
Patients will be randomly assigned to either active treatment (aspirin) or placebo.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Study Start Date : January 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1000 mg/day aspirin
1000 mg/day aspirin
 Drug: Aspirin
1000 mg/day of aspirin 1000 mg/day of sugar pill
Placebo Comparator: sugar pill
sugar pill
 Drug: Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047539


Contacts
Contact: Scott W Woods, MD 2039747038 scott.woods@yale.edu

Locations
United States, Connecticut
PRIME Research Clinic Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Scott W Woods, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Scott W Woods, MD Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02047539     History of Changes
Other Study ID Numbers: 1401013288
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics