Trials / Withdrawn
WithdrawnNCT05268497
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression
Assessment of Feasibility of Using Clinician-Directed Cognitive Behavior Therapy Supplemented by a Digital Application in Conjunction With Esketamine (SPRAVATO®) in Participants With Treatment-Resistant Depression
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esketamine | Esketamine will be self-administered as nasal spray. |
| BEHAVIORAL | Cognitive Behavioral Therapy (CBT) | Clinician-directed CBT supplemented by the Mindset app will be administered. |
| DRUG | Antidepressant | Antidepressant will be administered orally. |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2022-03-07
- Last updated
- 2025-04-27
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05268497. Inclusion in this directory is not an endorsement.