The OBSERVE Protocol

Part of paid clinical trials in Milford, Connecticut.

Sponsor
Yale University
Study ID
NCT06725277
Status
Recruiting
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Conditions

  • Major Depression Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spravato — DRUG
    Intranasal esketamine
  • IV Ketamine — DRUG
    IV ketamine

Study Details

This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.

Key Dates

Start date
Jan 21, 2024
Status verified
May 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: IV Ketamine
    Patients taking IV ketamine
  • Arm: Spravato
    Patients taking Spravato, an intranasal form of ketamine

Primary Outcome Measure

TSQM-9 [ Time Frame: baseline to 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Mood InstituteMilfordConnecticut06461
Lisa Harding, MD
[email protected]
203-701-9737
Lisa Harding, MD (PRINCIPAL_INVESTIGATOR)
Yale School of MedicineNew HavenConnecticut06512-
Emory UniversityAtlantaGeorgia30322
Brandon Kitay, MD, PhD
404-712-6939
University of MichiganAnn ArborMichigan48104
Sagar Parikh, MD
734-232-0011
LifeStance HealthMooreOklahoma73160
Rachel Dalthorp, MD
[email protected]
Houston Center for Advanced Psychiatric TreatmentBellaireTexas77401
Sandhya Prashad, MD
Sarah Hartigan
[email protected]
(832) 730 - 5196
Sandhya Prashad, MD (PRINCIPAL_INVESTIGATOR)

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Mood Institute· Milford, CTYale School of Medicine· New Haven, CTEmory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MILifeStance Health· Moore, OKHouston Center for Advanced Psychiatric Treatment· Bellaire, TX

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