Nuedexta in Treatment-Resistant Major Depression

NCT01882829 | Completed Phase 2 Results

• 2 other identifiers: GCO 13-0389IF1463152
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need, therefore, to identify well-tolerated, orally available compounds that target the NMDA receptor as a novel treatment approach for TRD. The current project aims to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan.

Conditions

Major Depressive Disorder; Treatment Resistant

Keywords

depression; major depressive disorder; treatment resistant; Nuedexta; dextromethorphan; antidepressant; glutamate; NMDA receptor

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  The Montgomery-Asberg Depression Rating Scale is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is s scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Primary outcome is change in MADRS at Visit 6 (Week 10). Higher values represent a worse outcome.

  At baseline and visit 6 (week 10)

Secondary Outcomes (10)

• Quality of Life Enjoyment and Satisfaction Questionnaire Short Form

  At baseline and Visit 6 (week 10)

• Range of Impaired Functioning Tool

  At baseline and Visit 6 (week 10)

• Sheehan Disability Scale

  At baseline and Visit 6 (week 10)

• Patient Rated Inventory of Side Effects (PRISE)

  up to 12 weeks

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  up to 12 weeks

Study Arms (1)

Nuedexta (dextromethorphan/quinidine)

EXPERIMENTAL

45/10 mg every 12 hours x 8 weeks

Drug: dextromethorphan/quinidine

Interventions

dextromethorphan/quinidine DRUG

up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects

Also known as: Nuedexta

Nuedexta (dextromethorphan/quinidine)

Eligibility Criteria

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

You may qualify if:

• Male or female participants, 18-65 years of age;
• Current primary Axis I diagnosis of major depressive disorder according to DSM-IV-TR criteria as determined by a psychiatrist and confirmed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID);
• Current treatment-resistant depression defined by a history of inadequate response to a minimum of 2 adequate antidepressant treatment trials determined by patient history and chart review and confirmed with the Antidepressant Treatment History Form (ATHF);
• Participants must be willing to discontinue treatment with concomitant medications that are disallowed by the study protocol;
• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

You may not qualify if:

• Lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, pervasive developmental disorders or mental retardation
• Diagnosis of a substance use disorder within the past 1 year ;
• Female participants who are pregnant, nursing, for may become pregnant;
• Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
• Participants with clinically significant abnormalities of laboratories, physical examination, or ECG;
• Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure;
• Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block
• Participants with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions;
• Participants judged to be at serious suicidal risk by the PI;
• Concomitant use with quinidine, quinine, or mefloquine;
• Participants with known hypersensitivity to dextromethorphan;
• Use with an MAOI or within 14 days of stopping an MAOI;
• Concomitant use with drugs that prolong QT interval and are metabolized by CYP2D6

Sponsors & Collaborators

• James Murrough: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Murrough JW, Wade E, Sayed S, Ahle G, Kiraly DD, Welch A, Collins KA, Soleimani L, Iosifescu DV, Charney DS. Dextromethorphan/quinidine pharmacotherapy in patients with treatment resistant depression: A proof of concept clinical trial. J Affect Disord. 2017 Aug 15;218:277-283. doi: 10.1016/j.jad.2017.04.072. Epub 2017 Apr 29.

  PMID: 28478356 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

dextromethorphan - quinidine combination

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. James W Murrough
• Organization: Icahn School of Medicine at Mount Sinai

james.murrough@mssm.edu

212-241-7574

Study Officials

• James Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 20, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 11, 2018
• Results First Posted: June 11, 2018

Record last verified: 2018-05

Locations

US (1)