Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03688100 · ClinicalTrials.gov registry record · Phase 4
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 494
- Enrollment target
NCT03688100: Completed Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT03688100 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 494 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03688100, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 494 participants
- Enrollment target
Study Summary
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
Primary Outcome
PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression)
Interventions
- BEHAVIORAL Behavioral Activation Therapy
- DRUG Medication Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2022-05-06 |
| Phase | Phase 4 |
What the finished NCT03688100 record still lists
NCT03688100 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Behavioral Activation Therapy is the first listed.
NCT03688100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03688100 about?
NCT03688100 is a clinical study titled "Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure". We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy...
What is the current status of trial NCT03688100?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 494 participants. The study started on 2018-11-09. Estimated completion is 2022-05-06.
What interventions are being tested in trial NCT03688100?
The interventions under investigation include: Behavioral Activation Therapy (BEHAVIORAL), Medication Management (DRUG).
Who is sponsoring clinical trial NCT03688100?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03688100's enrollment target sits among peer trials
494 178th of 2000 higher than 1,822 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03127267 · 495 participants · Phase 3
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
- NCT06400472 · 495 participants · Phase 1
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
- NCT05283720 · 496 participants · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- NCT06417775 · 496 participants · Phase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI