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Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT02153502
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Drug: AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination) Drug: Placebo Phase 2

Detailed Description:

It is estimated that up to approximately 200 patients will participate in the study at approximately 30 enrolling centers in the US.

Eligible patients for this study must have MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria, and have shown an inadequate response to standard antidepressant treatment.

This is a multicenter, randomized, double-blind, placebo-controlled, study of 10 weeks duration.

Following screening procedures for assessment of inclusion and exclusion criteria, eligible patients will be randomized into the study. Study medication will be administered orally twice a day (BID) (1 capsule in the morning and 1 capsule in the evening, approximately 12 hours apart) throughout the treatment period.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterium Modified Dextromethorphan Hydrobromide/Quinidine Sulfate) as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: AVP-786 Drug: AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)
AVP-786 capsules administered twice a day over a 10-week period

Placebo Comparator: Placebo Drug: Placebo
Placebo capsules administered twice a day over a 10-week period




Primary Outcome Measures :
  1. Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score [ Time Frame: Visit 5 (Day 70) Week 10 ]
    Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score in patients receiving AVP 786 compared with patients administered placebo


Secondary Outcome Measures :
  1. 17-item Hamilton Rating Scale for Depression (HAM-D17) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  2. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  3. 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  4. Sheehan Disability Scale (SDS) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  5. Clinical Global Impression of Severity of Illness (CGI-S) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  6. Clinical Global Impression of Change (CGI-C) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  7. EuroQOL 5 Dimension 5 Level (EQ-5D-5L) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  8. Patient Global Impression of Change (PGIC) [ Time Frame: Visit 5 (Day 70) Week 10 ]
  9. 7-item Generalized Anxiety Disorder (GAD-7) [ Time Frame: Visit 5 (Day 70) Week 10 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of major depressive episode ≤ 24 months in duration
  • HAM-D17 score ≥ 20.
  • Documented to not have a significant (25% or greater) change in QIDS-SR16 score between Screening and Baseline visits.
  • Patients have been deemed to have an inadequate response (less than 50% symptom reduction) to at least 1 but no more than 3 adequate antidepressant trials during the current depressive episode.
  • Patients must be receiving ongoing treatment with an adequate dose of antidepressants.
  • Body Mass Index (BMI) of 18-35 kg/m².

Exclusion Criteria:

  • History of myasthenia gravis.
  • Have cardiovascular concerns such as:

    • History of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes.
    • QTc using the Fridericia's formula (QTcF) at screening > 450 msec for males and > 470 msec for females based on central review at the screening visit, unless due to ventricular pacing.
    • Any family history of congenital QT interval prolongation syndrome.
  • Known hypersensitivity/intolerance to DM, Q, opiate drugs (codeine, etc.), or any other ingredient of the study medication.
  • Pose a current suicide risk, as evidenced by any of the following:

    • It is the judgment of the investigator that the subject may be at risk for suicide.
    • The subject is rated a "yes" to question 4 or question 5 on the Baseline C-SSRS, if the most recent episode occurred within the past 12 months.
    • The subject has attempted suicide within the past 6 months
  • Presence of any other current DSM-IV-TR Axis I disorders with the exception of: generalized anxiety disorder (GAD: 300.02), social anxiety disorder (300.23), dysthymic disorder (300.4), or specific phobia (300.29). Patients with co-morbid GAD, social anxiety disorder, or specific phobia are ineligible if the co-morbid condition is clinically unstable, or has been the primary focus of treatment within the 6 month period prior to screening
  • Axis I diagnosis of:

    • Delirium, dementia, amnestic, or other cognitive disorder;
    • Schizophrenia or other psychotic disorder, based on the M.I.N.I.;
    • Bipolar I or II disorder, based on the M.I.N.I.
  • Clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153502


  Show 32 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02153502     History of Changes
Other Study ID Numbers: 14-AVP-786-201
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Dextromethorphan
Quinidine
Quinidine gluconate
Psychotropic Drugs
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors