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

First listed
Dec 10, 2024
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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