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Major Depressive DisorderPhase 2/3NCT01318434

A 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)

A Phase 2/3 study testing EB-1010 25mg BID, SSRI Active and EB-1010 50mg BID in people with Major Depressive Disorder, run by Euthymics BioScience, Inc. at 43 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

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
EB-1010 25mg BID, SSRI Active and EB-1010 50mg BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
342 participants
Where
43 sitesUnited States
Study dates
Feb 2011to Feb 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 18-40.
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  • 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.
  • Meet DSM-IV-TR criteria (by Structured Clinical Interview for DSM-IV-TR - SCID-CT) for MDD, current.
  • Treated with one of the allowed SSRIs or SNRIs at adequate doses (defined as 20mg/day or more of citalopram; 10 mg/day or more of escitalopram, 50mg/day or more of sertraline; 125 mg/day or more of venlafaxine; 60 mg/day or more of duloxetine) during the current episode for at least 8 weeks, with the same, adequate dose over the last 4 weeks.
  • Between the screen and baseline visits, patients must be documented to have less than a 25% reduction in QIDS-SR score.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. Adequate methods are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable or patch hormonal contraception, oral contraceptives, an IUD, double-barrier contraception, sexual abstinence. Form of birth control will be documented at screening and baseline.
  • WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ³ 12 consecutive months); or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.

Who cannot join

  • 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).
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  • 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.
  • Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months, based on the SCID-CT.
  • Patients receiving new-onset psychotherapy and/or somatic therapy (light therapy, trans-cranial magnetic stimulation) within 6 weeks of screening, or at any time during participation in the trial.
  • Patients who, in the opinion of the Investigator, are actively suicidal and at significant risk for suicide.
  • Patients who have participated in any clinical trial with an investigational drug or device within the past month.
  • Patients who routinely perform shift work and whose sleep-wake cycle is frequently changed because of their work.
  • Patients who have received ECT in the past 20 years or Vagal Nerve/Deep Brain Stimulation during their lifetime.
  • Unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
  • Subjects with evidence or history of significant neurological disorder, including head trauma with loss of consciousness, history of stroke, Parkinson's disease, epilepsy disorder, conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), who are taking medications to control seizures, or who have increased risk of seizures as evidenced by history of EEG with epileptiform activity (with the exception of juvenile febrile seizures).
  • Subjects who are known to have AIDS or to be HIV positive.
  • Patients with a significant history of drug or food allergy or hypersensitivity. Specifically, patients who report a history of drug-induced and/or food-induced asthma, facial-swelling, tongue swelling, angioedema, urticaria, stridor, hives, epiglottis swelling, recurrent skin rashes, toxic epidermal necrolysis, or Stevens-Johnson Syndrome.
  • Patients who, in the Investigator's judgment represent a significant risk of committing suicide during the course of the trial based on history or evaluation of current mental status. Patients with significant hostility and history of aggressive acts who, in the Investigator's judgment, represent a significant risk of committing violent acts during the course of the trial based on history or evaluation of current mental status.
  • Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial.
  • Patients with thyroid pathology (unless condition has been stabilized with medications for at least the past three months).
  • Patients with a lifetime history of serotonin syndrome.
  • Patients with a significant history of a seizure disorder.
  • Patients who have received a vaccination in the past three months.
  • Patients with a recent (within two weeks) viral or systemic illness.
  • Patients with current skin rashes.
  • Patients who have recently (within two weeks) begun any medications.
  • Patients who have a positive urine drug screen which cannot be explained by prescribed medications.
  • Patients with AST and/or ALT >2x ULN at the screening visit.
  • Patients with abnormal thyroid-stimulating hormone (TSH) concentrations or positive hepatitis tests.
  • Patients with clinically significant laboratory abnormalities (hematology, chemistry, urinalysis) or with Safety Values of Potential Clinical Concern (see Table 3).
  • Diastolic blood pressure > 105 mmHg at screen or baseline.
  • Any signs or symptoms that are, in the Investigator's judgment, medically significant, in that they would impact the patient's safety.
  • Patients with a QTc value of 460 ms or greater.
  • Patients who are known to be allergic or hypersensitive to paroxetine and EB-1010.
  • Patients previously treated with and not responding to paroxetine
  • Monoamine oxidase inhibitors (e.g., Nardil, phenelzine, Parnate, tranylcypromine, Marplan, isocarboxazide) treatment within the 2 weeks prior to enrollment.
  • Patients who would likely require prohibited concomitant medications and/or other depression treatment during the trial.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
  • Patients who demonstrate a 25% or greater decrease in depressive symptoms as reflected by the QIDS-SR19 total score from screen visit to baseline visit.
  • Patients who plan to have elective surgeries during the course of the study.
  • Patients with a history of antidepressant-induced hypomania or dysphoria.
  • Patients who demonstrate a less than 80% compliance (as measured by pill count) of their antidepressant medication during the Screening Phase.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Pacific Clinical Research Medical Group

    Arcadia, California, 91007

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Southwest Research, Inc.

    Beverly Hills, California, 90210

  • Southeastern PA Medical Institute

    Broomall, Pennsylvania, 19008

  • Cambridge Health Alliance

    Cambridge, Massachusetts, 02139

  • Community Research

    Cincinnati, Ohio, 45227

  • Sanitas Research

    Coral Gables, Florida, 33134

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Radiant Research, Inc.

    Denver, Colorado, 80239

  • AccelRx Research

    Fall River, Massachusetts, 02721

  • Clinical Insights

    Glen Burnie, Maryland, 21061

  • Radiant Research

    Greer, South Carolina, 29651

  • Clinical Neuroscience Solution, Inc.

    Jacksonville, Florida, 32216

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70601

  • Florida Clinical Research Center

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical NeuroScience Solutions, Inc.

    Memphis, Tennessee, 38119

  • North Star Medical Research

    Middleburg Heights, Ohio, 44130

  • Dean Foundation for Health, Research & Education

    Middleton, Wisconsin, 53562

  • Radiant Research, Inc.

    Murray, Utah, 84123

  • AMR Baber Research

    Naperville, Illinois, 60563

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Synergy Clinical Research Center

    National City, California, 91950

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • CRI Worldwide

    Philadelphia, Pennsylvania, 19139

  • Global Medical Institutes

    Princeton, New Jersey, 08540

  • VCU

    Richmond, Virginia, 23219

  • St Charles Psychiatric Associates

    Saint Charles, Missouri, 63301

  • Medical Research Group of Central Florida

    Sanford, Florida, 32771

  • Clinical Innovations, Inc.

    Santa Ana, California, 92705

  • Scranton Counseling Center

    Scranton, Pennsylvania, 18503

  • Behavioral Medical Research of Staten Island

    Staten Island, New York, 10305

  • Psychiatric Medicine Associates

    Stokie, Illinois, 60076

  • Neurology and Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

  • CRI Worldwide, LLC

    Willingboro, New Jersey, 08046

Other trials in United States

About this study

Official title: 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)

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.

Being tested
EB-1010 25mg BID, SSRI Active, EB-1010 50mg BID, Placebo
Keywords
Outpatient
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • EB-1010 25mg BIDDrug

    capsule once daily

  • SSRI ActiveDrug

    Active Comparator

  • EB-1010 50mg BIDDrug

    Experimental Active

  • PlaceboDrug

    Placebo comparator

Study groups in NCT01318434
Study groupRoleWhat they receive
EB-1010 25 mg BIDExperimentalExperimental Active
Receives: Drug: EB-1010 25mg BID
EB-1010 50 mg BIDExperimentalExperimental Active
Receives: Drug: EB-1010 50mg BID
SSRI/SNRIActive comparatorActive Comparator
Receives: Drug: SSRI Active
EB-1010 0 mg BIDPlacebo comparatorPlacebo comparator
Receives: Drug: Placebo

What is being measured

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

  1. Change from baseline in MADRS Score

    Improvement in MADRS Score

    Measured: 6 weeks

Secondary outcomes (1)

  1. Change in Clinical Global Severity Scale

    Degree of clinical global severity improvement

    Measured: 6 weeks

Timeline

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

  1. First posted18 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01318434
Sponsor's protocol ID
EB-1010-301
Status last verified
Nov 2015
First submitted
9 Mar 2011
Last updated
4 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing EB-1010 25mg BID, SSRI Active and EB-1010 50mg BID in people with Major Depressive Disorder, run by Euthymics BioScience, Inc. at 43 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 15 inclusion and 46 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 4 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 43 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in MADRS Score (time frame: 6 weeks). 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 NCT01318434.

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 4 Dec 2015.

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