A Clinical Evaluation for the Management of Patients With Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Disorder, Major
- Sponsor
- Abbott Medical Devices
- Enrollment
- 125
- Locations
- 13
- Primary Endpoint
- Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months: however, all patients will be followed for 1 year. A total of 201 patients will be randomized from up to 20 sites.
Each potential patient will be pre-screened according to the inclusion/exclusion criteria. A narrative of what study participation entails, will be used to educate potential participants on study requirements. Prior to on-site baseline evaluations, the patient will sign the informed consent. Patients will then undergo 3 baseline evaluations, with each of these evaluations to occur no less than 2 weeks apart from each other. The first 2 baseline visit evaluations will be performed by separate psychiatrists in order to confirm the patient's diagnosis. All patients will be scheduled for surgery, to occur no less than two weeks and no more than 1 month after final baseline evaluation, to implant the ANS Libra® Deep Brain Stimulation system. After device implantation, patients will be randomly assigned to 1 of 2 groups in a 2:1 ratio (Active Treatment Group & Control Group).
After system implant (Week 0), the patient will return to clinic approximately 2 weeks after surgery for evaluation and treatment randomization into either Group 1 or Group 2 (Group 1 = Active Treatment Group; Group 2 = Control Group). Patient will then return to clinic for subsequent evaluations at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 1 year post system implantation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women (non-pregnant) age is 21-70 years;
- •Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria derived from the MINI;
- •First episode onset before age 45;
- •Current episode ≥ 12 months duration;
- •In the current episode: Documented resistance (i.e.persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's, SNRI's, TCA's, MAO inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria;
- •In Lifetime: Received a course of psychotherapy for depression;
- •Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 22 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 MADRS scores cannot be separated by \> 6 weeks and cannot improve ≥ 20%;
- •Global Assessment of Function, score \<50;
- •Modified mini-mental state examination (MMSE) score ≥24;
- •No change in current antidepressant medication regimen or medication free ≥4 weeks prior to study entry (with exception to sleep, cholesterol, blood pressure, sexual dysfunction, non-migraine headache medication, or medication for other medical reasons not related to depression, in which changes to dose or type will be allowed during course of study);
Exclusion Criteria
- •A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
- •Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, and screened via SCID-II at Baseline visit;
- •In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
- •Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, chronic migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
- •Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
- •Has been currently diagnosed with chronic fatigue syndrome;
- •Substantial suicidal risk as defined by (1) MADRS item 10 score of 5 or 6, (2) a current plan and intent,(3) clinician judgment that there is a clear immediate intent for self-harm, (4) more than 3 suicide attempts within the last 12 months;
- •Co-morbid obsessive compulsive disorder, posttraumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI;
- •Alcohol, medication, or illegal substance dependence or abuse within last 12 months derived from the MINI;
- •Diagnosis of sleep apnea confirmed by a sleep test that is not adequately treated;
Outcomes
Primary Outcomes
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
Time Frame: Baseline to 6 months
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.
Secondary Outcomes
- Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration(6 months-1 year)
- Hamilton Rating Scale for Depression - 17 Item (HRSD-17) Score at Baseline and 6 Months(6 months)
- Baseline MADRS to MADRS at 1 Year(Baseline to 1 year)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score From Baseline to 1 Year(1 year)
- Inventory of Depressive Symptomology (IDS-C30) Score From Baseline to 1 Year(1 year)
- Work and Social Adjustment Scale (WSAS) Score From Baseline to 1 Year(1 year)
- Global Assessment Scale (GAF) Score at Baseline and 1 Year(1 year)
- Quick Inventory of Depressive Symptomatology (QIDS-SR) Scores From Baseline to 1 Year(1 year)