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NCT04235712
Implementation of Harmonized Depression Outcome Measures in a Health System
trial testing Harmonized Depression Outcome Measures in Major Depression in 5 participants. Completed in 15 May 2021.
15 May 2021
Quick facts
| Lead sponsor | OM1, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 5 |
| Start date | 17 November 2020 |
| Primary completion | 15 May 2021 |
| Estimated completion | 15 May 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Harmonized Depression Outcome Measures
Conditions studied
- Major Depression — all drugs for Major Depression →
- Dysthymia — all drugs for Dysthymia →
Sponsor
OM1, Inc.
Who can join
18 and older, any sex, with Major Depression or Dysthymia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The PHQ-9 will be captured either at an office visit or directly from patients. The investigators will build and implement an open-source SMART on FHIR app to collect key data from the EHR, combine that data with the PHQ-9 results, and present the measurements back to the clinicians. The investigators will then obtain feedback from clinicians on the value and usefulness of the app.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04235712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Harmonized Depression Outcome Measures
Trials testing the same drug.
- NCT04235725 — Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry · completed
Other recruiting trials for Major Depression
Currently open trials in the same condition.
- NCT07031817 — Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Di · NA · recruiting
- NCT07184697 — Efficacy and Safety of Task-specific, Biomarker-driven, HD-ctACS inTRD. · NA · active not recruiting
- NCT07463911 — Treatment Response In ECT Patients · active not recruiting
- NCT06763081 — Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation · recruiting
- NCT06781593 — Combining Light Therapy and CPAP in Depression · NA · recruiting
Other OM1, Inc. trials
Trials by the same sponsor.
- NCT05084417 — A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions · unknown
- NCT04235725 — Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04235712 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by OM1, Inc.
- Last refreshed: 18 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04235712.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing