Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2024-01-21
2029-12-31
Brief Summary
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This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IV Ketamine
Patients taking IV ketamine
IV Ketamine
IV ketamine
Spravato
Patients taking Spravato, an intranasal form of ketamine
Spravato
Intranasal esketamine
Interventions
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Spravato
Intranasal esketamine
IV Ketamine
IV ketamine
Eligibility Criteria
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Inclusion Criteria
1. Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects.
OR
2. Scheduled to receive standard clinical treatment with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features. These patients are referred to as treatment-initiating subjects.
In addition, in order to be eligible, an individual must meet all of the following additional criteria:
3. Adult ages 18 or older
4. Provision of signed and dated informed consent form prior to any study procedures
5. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria
1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
3. Active or recent (within 12 months) substance use disorder (other than nicotine)
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Samuel Wilkinson, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Mood Institute
Milford, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
LifeStance Health
Moore, Oklahoma, United States
Houston Center for Advanced Psychiatric Treatment
Bellaire, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Brandon Kitay, MD, PhD
Role: primary
Sagar Parikh, MD
Role: primary
Sandhya Prashad, MD
Role: primary
Other Identifiers
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23-005287
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000038673
Identifier Type: -
Identifier Source: org_study_id
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