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

NCT02153502 | Completed Phase 2 DMC

• 1 other identifier: 14-AVP-786-201
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 32

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.

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

• Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score

  Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score in patients receiving AVP 786 compared with patients administered placebo

  Visit 5 (Day 70) Week 10

Secondary Outcomes (9)

• 17-item Hamilton Rating Scale for Depression (HAM-D17)

  Visit 5 (Day 70) Week 10

• Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)

  Visit 5 (Day 70) Week 10

• 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)

  Visit 5 (Day 70) Week 10

• Sheehan Disability Scale (SDS)

  Visit 5 (Day 70) Week 10

• Clinical Global Impression of Severity of Illness (CGI-S)

  Visit 5 (Day 70) Week 10

Study Arms (2)

AVP-786

EXPERIMENTAL

Drug: AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination) DRUG

AVP-786 capsules administered twice a day over a 10-week period

AVP-786

Placebo DRUG

Placebo capsules administered twice a day over a 10-week period

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (32)

Unknown Facility

Birmingham, Alabama, 35213, United States

Location

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Birmingham, Alabama, 35294, United States

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Bellflower, California, 90706, United States

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Costa Mesa, California, 92626, United States

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Garden Grove, California, 92845, United States

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Lomita, California, 90717, United States

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Oceanside, California, 92056, United States

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Riverside, California, 92506, United States

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Santa Ana, California, 92706, United States

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Sherman Oaks, California, 91403, United States

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Denver, Colorado, 80239, United States

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Bradenton, Florida, 34201, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33155, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32801, United States

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Decatur, Georgia, 30030, United States

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Hoffman Estates, Illinois, 60169, United States

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Valparaiso, Indiana, 46383, United States

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Baltimore, Maryland, 21285, United States

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Glen Burnie, Maryland, 21061, United States

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Boston, Massachusetts, 02131, United States

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Brooklyn, New York, 11241, United States

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New York, New York, 10003, United States

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Staten Island, New York, 10312, United States

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Garfield Heights, Ohio, 44125, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74101, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19139, United States

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Unknown Facility

Murray, Utah, 84123, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 3, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (32)