A Double-Blind, Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (Triple Reuptake Inhibitor Anti-Depressant Effects - TRIADE Study)

Euthymics BioScience, Inc.41 sites in 1 country342 target enrollmentFebruary 2011

ConditionsMajor Depressive Disorder

InterventionsEB-1010 25mg BID EB-1010 50mg BID SSRI Active Placebo

DrugsEB-1010 25mg BID SSRI Active EB-1010 50mg BID Placebo

Overview

Phase: Phase 2
Intervention: EB-1010 25mg BID
Conditions: Major Depressive Disorder
Sponsor: Euthymics BioScience, Inc.
Enrollment: 342
Locations: 41
Primary Endpoint: Change from baseline in MADRS Score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main research hypothesis for this study is that, among patients with Major Depressive Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at the dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the sequential parallel comparison design. The secondary research hypothesis for this study is that, among patients with MDD who have responded inadequately to treatment with SSRIs or SNRIs, the degree of improvement in depressive symptoms, as assessed by the MGH Cognitive and Physical Functioning Questionnaire (MGH CPFQ) will be significantly greater among those treated with EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

February 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Euthymics BioScience, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be able to give informed consent, (as required by IRB/IEC), prior to the initiation of any protocol required procedures.
•Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
•Patients with a diagnosis of major depressive episode as defined by DSM-IV-TR criteria, based on the SCID-CT29; their major depressive episode must be deemed "valid" using the SAFER criteria interview24 administered by remote, independent raters.
•Patients who have reported a history for the current depressive episode of an inadequate response to 1 and no more than 1 adequate SSRI or SNRI treatment. An inadequate response is defined as less than a 50% reduction in depressive symptom severity, as assessed by the MGH ATRQ administered by remote, independent raters. An adequate trial is defined as an antidepressant treatment for at least 8 weeks duration at least at the minimum dose as specified in the MGH ATRQ.
•Patients must have a 17-item Hamilton Rating Scale for Depression (HAM-D-17) (whose score is derived from the HAM-D-28)20 score ≥ 18 during the screening phase to qualify for inclusion. The HAM-D-28 will be administered by the study clinicians at the screening and baseline visits, and by remote, independent raters during the screening phase at the time of the SAFER interview.
•Patients must have a Body Mass Index (BMI) of approximately 18-
•Patients must be able to be reliably rated on the psychiatric scales required by the protocol based on Investigator's judgment.
•Patients must be able to understand and read English.
•Placebo non-responders are defined as those patients who failed to achieve at least a 50% decrease in their MADRS score at visit 8 (Week 6), AND have a MADRS score of = or \> 16 at visit 8 (Week 6)
•Men and women, ages 18 to 65 inclusive.

Exclusion Criteria

•WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period \[and for up to 4 weeks after the last dose of investigational product.
•WOCBP using a prohibited contraceptive method that does not meet established and acceptable medical standards.
•Women who are pregnant or breastfeeding.
•Women with a positive pregnancy test on enrollment or prior to investigational product administration.
•Sexually active fertile men not using effective birth control if their partners are WOCBP.
•Patients who do not report any prior inadequate response (equal or greater than 50% decrease in depressive symptom severity) or report an inadequate response (less than 50% decrease in depressive symptom severity) to more than 1 prior adequate trials of antidepressant treatments during the current depressive episode (including monotherapy treatment and distinct combination regimens) at a therapeutic dose (as defined by the MGH ATRQ)22-23 and for an adequate duration (minimum 6 weeks for any monotherapy).
•Patients who report treatment with adjunctive medication (buspirone, atypical antipsychotics, lithium) to their antidepressant therapy for a minimum of 4 weeks during the current depressive episode.
•Patients with a current need for involuntary commitment or who have been hospitalized within 4 weeks of the Screening Visit for the current major depressive episode.
•Subjects with other DSM-IV-TR Axis I disorders other than Generalized Anxiety Disorder (GAD: 300.02), Social Anxiety Disorder (300.23), or Specific Phobia (300.29). Subjects with co-morbid GAD, Social Anxiety Disorder, or Specific Phobia are ineligible if the co-morbid condition is clinically unstable, requires treatment, or has been the primary focus of treatment within the 6 month period prior to screening. More specifically, patients who have a current Axis I diagnosis
•Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current or any previous depressive episode.