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Major Depressive DisorderNCT00320372

Treatment-Resistant Depression Registry

An observational study of Major Depressive Disorder, run by Cyberonics, Inc. at 55 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
How many people
795 participants
Where
55 sitesUnited States
Study dates
Jan 2006to May 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chronic depression that is at least two years in duration or a recurrent depression that includes at least three lifetime episodes including the current major depressive episode (MDE); and an inadequate response to four or more adequate antidepressant treatments.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Suburban Psychiatric Associates

    Amherst, New York, 14228

  • Pharmasite Research Inc.

    Baltimore, Maryland, 21208

  • Sheppard Pratt Health Systems, Inc.

    Baltimore, Maryland, 21285

  • Cedars-Sinai Hospital

    Beverly Hills, California

  • Florida Atlantic University

    Boca Raton, Florida, 33431

  • MG Martelli, MD, PC and Associates

    Brunswick, Georgia, 31520

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Massachusetts General Hospital

    Charlestown, Massachusetts, 02129

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Arthur Holt, Private Practice

    Columbus, Georgia

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8898

  • Pact Atlanta, LLC

    Decatur, Georgia, 30030

  • Northshore University Health System

    Evanston, Illinois, 60201

  • McGrath Clinic

    Evergreen Park, Illinois

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-1410

  • Century Health

    Findlay, Ohio, 45840

  • Precise Research Centers

    Flowood, Mississippi

  • University of Florida

    Gainesville, Florida, 32610-0256

  • Mark Zetin, MD - Private Practice

    Garden Grove, California, 92840

  • Clinical Insights

    Glen Burnie, Maryland, 21061

  • Alexian Brothers Behavioral Health Hospital

    Hoffman Estates, Illinois

  • Claghorn-Lesem Reserach Clinic, Ltd.

    Houston, Texas, 77008

  • Baylor College of Medicine

    Houston, Texas

  • 3c Methodist Hospital

    Indianapolis, Indiana

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Loma Linda University

    Loma Linda, California

  • Private Practice

    Macon, Georgia, 31201

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • Center for Anxiety and Depression

    Mercer Island, Washington, 98040

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Columbia University

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Western Psychiatric Institute & Clinic (WPIC)

    Pittsburgh, Pennsylvania, 15213

  • The Mech Center

    Plano, Texas

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • Fair Oaks Psychiatric Associates

    Sacramento, California

  • Psychiatric Recovery

    Saint Paul, Minnesota, 55114

  • Psychiatric & Behavioral Solutions

    Salt Lake City, Utah, 84105

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Alamo Superior Research

    San Antonio, Texas

  • Louisiana Clinical Research, LLC

    Shreveport, Louisiana, 71115

  • Psychiatric Medicine Associates, LLC

    Skokie, Illinois, 60076

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Psych Care Consultants Research

    St Louis, Missouri, 63128

  • SUNY UMU at Syracuse

    Syracuse, New York, 13210

  • University of Arizona

    Tucson, Arizona, 85724

  • Valdosta Psychiatric Associates LLC

    Valdosta, Georgia, 31602

  • Dupage Mental Health Services

    Wheaton, Illinois, 60187

  • Clinical Research Institute

    Wichita, Kansas

  • Wake Forest University - Health Sciences

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Long-term, Prospective, Observational, Multi-center Patient Outcome Registry to Collect Data in Patients With Treatment-resistant Depression (TRD) Who Are Currently in a Major Depressive Episode.

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.

Read the detailed description

Enrollment of TRD patients treated with VNS Therapy will consist of patients originally enrolled in the registry as well as patients who have completed the D-21 Dosing Study and are enrolled in the Registry for Long-Term Follow-up. Sites will maintain a screening log of all patients who have been screened for original TRD Registry patients.

Please note that because this is a post-approval registry, Cyberonics does not cover the cost of VNS Therapy implantation.

Keywords
Major Depressive Disorder, Treatment-resistant Depression
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00320372
Study groupRoleWhat they receive
1. 500 VNS PatientsVNS Patients - Treatment-resistant depression patients treated with VNS Therapy.
2. 300 Non-VNS PatientsNon-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)

    Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a "Responder" (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A "Non-Responder" (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline.

    Total number of patients in each group may be lower than ITT in a case of missing assessment data.

    Measured: 3-Month Through 60-Month (Post Baseline)

Secondary outcomes (6)

  1. Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)

    Recurrence based on MADRS is defined as first time attained MADRS total score ≥ 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.

    Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated.

    Measured: 3-Month Through 60-Month (Post Baseline)

  2. Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)

    Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. Total number of patients in each group may be lower than ITT in a case of missing assessment data.

    Measured: 3-Month Through 60-Month (Post Baseline)

  3. Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation

    This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).

    Total number of patients analyzed may be lower than ITT in a case of missing assessment data.

    Measured: 1 Week Pre-Baseline

  4. Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture

    This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.

    Total number of patients analyzed may be lower than ITT in a case of missing assessment data.

    Measured: Baseline

  5. Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture

    This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.

    Total number of patients analyzed may be lower than ITT in a case of missing assessment data.

    Measured: Baseline

  6. Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE

    This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.

    Measured: Screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
795 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00320372
Sponsor's protocol ID
TRD Registry
Status last verified
Dec 2015
First submitted
1 May 2006
Last updated
23 Dec 2015
Data monitoring committee
No

Publications

  • Rush AJ, Sackeim HA, Marangell LB, George MS, Brannan SK, Davis SM, Lavori P, Howland R, Kling MA, Rittberg B, Carpenter L, Ninan P, Moreno F, Schwartz T, Conway C, Burke M, Barry JJ. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry. 2005 Sep 1;58(5):355-63. doi: 10.1016/j.biopsych.2005.05.024.

    PubMed 16139581

  • Rush AJ, Marangell LB, Sackeim HA, George MS, Brannan SK, Davis SM, Howland R, Kling MA, Rittberg BR, Burke WJ, Rapaport MH, Zajecka J, Nierenberg AA, Husain MM, Ginsberg D, Cooke RG. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry. 2005 Sep 1;58(5):347-54. doi: 10.1016/j.biopsych.2005.05.025.

    PubMed 16139580

  • George MS, Rush AJ, Marangell LB, Sackeim HA, Brannan SK, Davis SM, Howland R, Kling MA, Moreno F, Rittberg B, Dunner D, Schwartz T, Carpenter L, Burke M, Ninan P, Goodnick P. A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression. Biol Psychiatry. 2005 Sep 1;58(5):364-73. doi: 10.1016/j.biopsych.2005.07.028.

    PubMed 16139582

  • Bajbouj M, Merkl A, Schlaepfer TE, Frick C, Zobel A, Maier W, O'Keane V, Corcoran C, Adolfsson R, Trimble M, Rau H, Hoff HJ, Padberg F, Muller-Siecheneder F, Audenaert K, van den Abbeele D, Matthews K, Christmas D, Eljamel S, Heuser I. Two-year outcome of vagus nerve stimulation in treatment-resistant depression. J Clin Psychopharmacol. 2010 Jun;30(3):273-81. doi: 10.1097/JCP.0b013e3181db8831.

    PubMed 20473062

  • McAllister-Williams RH, Sousa S, Kumar A, Greco T, Bunker MT, Aaronson ST, Conway CR, Rush AJ. The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry. Int J Bipolar Disord. 2020 May 2;8(1):13. doi: 10.1186/s40345-020-0178-4.

    PubMed 32358769

  • Aaronson ST, Sears P, Ruvuna F, Bunker M, Conway CR, Dougherty DD, Reimherr FW, Schwartz TL, Zajecka JM. A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. Am J Psychiatry. 2017 Jul 1;174(7):640-648. doi: 10.1176/appi.ajp.2017.16010034. Epub 2017 Mar 31.

    PubMed 28359201

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Cyberonics, Inc. at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline) (time frame: 3-Month Through 60-Month (Post Baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320372, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.

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Treatment-Resistant Depression Registry (NCT00320372) | AzTrials