N/A
N=795
Treatment-Resistant Depression Registry
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00320372 ↗Enrolled (actual)
795
Serious AEs
—
Results posted
Dec 2015
Primary outcome: Primary: Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline) — 24; 8.8; 28; 13.8 Percentage of Participants — p=<.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cyberonics, Inc.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline) |
24; 8.8; 28; 13.8; 33.8; 13.5 | <.0001 sig |
| SECONDARY Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS) |
14; 9; 40; 19 | 0.1015 |
| SECONDARY Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline) |
8.6; 2.8; 15; 6.3; 16.2; 5.7 | <.0001 sig |
| SECONDARY Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation |
6.03; 28.83; 25.56; 18.87; 14.81; 4.72 | <0.0001 sig |
| SECONDARY Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture |
46.70; 3.14; 5.61; 3.47; 8.91; 18.15 | <.0001 sig |
| SECONDARY Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture |
46.86; 3.80; 2.31; 5.12; 11.06; 12.05 | <.0001 sig |
| SECONDARY Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE |
16.99; 40.39; 5.88; 11.24; 5.75; 9.41 | .0012 sig |
Summary
This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the current episode, during the patient's lifetime AND has not adequately responded to 4 or more adequate antidepressive treatments. The registry will follow the clinical course and outcomes for patients with TRD who are treated with and without adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS) therapy.
Eligibility Criteria
Inclusion Criteria
- Patient diagnosed with a current major depressive episode according to DSM-IV-TR criteria.
- For D-21 patients only who have completed the D-21 dosing Study without any D-21 inclusion and exclusion protocol deviation.
- Patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current MDE.
- Patient has had an inadequate response to 4 or more adequate antidepressive treatments.
- The patient has a CGI severity of illness score of moderately ill (score of 4) or greater.
- The patient must be able to provide informed consent and complete all forms.
Exclusion Criteria
- Patient has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic.
- Patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind D-21 study will be allowed to enter the Registry for Long Term Follow-up
- Other than those patients who were enrolled in the D-21 study, patient has previously received VNS therapy.
- Patient has a history of rapid cycling bipolar disorder.
Data sourced from ClinicalTrials.gov (NCT00320372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.