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Nuedexta in Treatment-Resistant Major Depression

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ClinicalTrials.gov Identifier: NCT01882829
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Treatment Resistant
Intervention Drug: dextromethorphan/quinidine
Enrollment 20

Recruitment Details Recruitment period from October 2013 to December 2015
Pre-assignment Details  
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description

45/10 mg every 12 hours x 8 weeks

dextromethorphan/quinidine: 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

Period Title: Overall Study
Started 20
Completed 14
Not Completed 6
Reason Not Completed
Adverse Event             4
Protocol Violation             1
Withdrawal by Subject             1
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
49.4  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Montgomery-Asberg Depression Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
32.5  (3.9)
[1]
Measure Description: The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Clinical Global Impression - Severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
4.5  (0.5)
[1]
Measure Description: a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale
Hide Description 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.
Time Frame At baseline and visit 6 (week 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-13.0  (11.5)
2.Secondary Outcome
Title Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Hide Description The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form is a reliable and valid self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by individuals. The raw total score ranges from 14 to 70. Higher scores reflect better oucomes.
Time Frame At baseline and Visit 6 (week 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
0.1  (0.2)
3.Secondary Outcome
Title Range of Impaired Functioning Tool
Hide Description

The Range of Impaired Functioning Tool a brief scale for assessing functional impairment related to medical or psychiatric illness and has been demonstrated to possess good psychometric properties. The LIFE-RIFT has a total score and individual domain scores for the following areas of functioning: household duties, work, recreation, relationships with family, relationships with friends, schoolwork, and global life satisfaction (the satisfaction item is patient rated).

Higher scores indicate poorer functioning; scores ≥2 reflect impaired functioning in that domain. Results are reported for the total sum with full range from 3 (no impairment) to 60 (severe impairment), which is based on all individual domain scores.

Time Frame At baseline and Visit 6 (week 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
missing data on 2 participants
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-3.7  (4.1)
4.Secondary Outcome
Title Sheehan Disability Scale
Hide Description The Sheehan Disability Scale (SDS) is a self-rated scale which assesses illness-related disability in three areas of functioning: work, social and family. The SDS assess disability or functional impairment across three domains: work/school, social life/leisure activities and family life/home responsibilities. Each domain is scored from 0 (not at all) to 10 (very severely). The three domains can be summarized to evaluate global functional impairment by adding the scores of each of the three domains, resulting in global SDS score ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame At baseline and Visit 6 (week 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-4.3  (7.4)
5.Secondary Outcome
Title Patient Rated Inventory of Side Effects (PRISE)
Hide Description Frequency of observed adverse events over the study treatment period as captured by the PRISE. The Patient Rated Inventory of Side Effects (PRISE) assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other).
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: events
25
6.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
missing data on one participant
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
0.1  (0.5)
7.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Hide Description The Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) is a 16-item self rated instrument designed to assess the severity of depressive symptoms (30). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-5.9  (6.6)
8.Secondary Outcome
Title Clinical Global Impression (CGI) Scale
Hide Description The Clinical Global Impression (CGI) scale assesses overall treatment response in psychiatric patients and has good reliability and validity metrics. The administration time is 2 minutes. This scale consists of three items: Severity of Illness (item 1); Global Improvement (item 2); and Efficacy Index (item 3). Item 1 is rated on a seven-point scale (1 = normal, 7 = among the most extremely ill patients) as is item 2 (1 = very much improved, 7 = very much worse). Full scale is 1 to 14.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-1.5  (1.3)
9.Secondary Outcome
Title Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Hide Description The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a brief scale to measure cognitive and executive dysfunction in mood and anxiety disorders, and possesses good reliability and validity. The Massachusetts General Hospital CPFQ was developed to assess each of the 7 most common complaints of depressed patients reporting fatigue or cognitive/executive problems. The CPFQ consists of 7 questions, each rated on a scale from 1 to 6, with 1 indicating greater than normal functioning, 2 indicating normal functioning and with higher numbers indicating poorer functioning. Total score range from 7 (greater than normal function) to 42 (poor function).
Time Frame At baseline and Visit 6 (week 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-4.1  (6.5)
10.Secondary Outcome
Title HAM-A
Hide Description Change in Hamilton Anxiety Rating Scale (HAM-A) score from baseline to Week 10. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and >25-30 moderate to severe.
Time Frame Baseline and Week 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-5.7  (5.9)
11.Secondary Outcome
Title Beck Scale for Suicidal Ideation (BSI)
Hide Description Mean change in Brief Inventory Symptom from baseline to week 10. The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items are intended to assess a patient’s thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). In this study, scores from the five screening items were included in the overall score. Therefore, total scores could range from 0 to 48, with higher scores reflecting more severe symptoms.
Time Frame Baseline and Week 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description:
up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
-2.5  (5.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nuedexta (Dextromethorphan/Quinidine)
Hide Arm/Group Description up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week
All-Cause Mortality
Nuedexta (Dextromethorphan/Quinidine)
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nuedexta (Dextromethorphan/Quinidine)
Affected / at Risk (%)
Total   1/20 (5.00%) 
Psychiatric disorders   
Insomnia  1/20 (5.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nuedexta (Dextromethorphan/Quinidine)
Affected / at Risk (%)
Total   20/20 (100.00%) 
Cardiac disorders   
Palpitations  1/20 (5.00%) 
Eye disorders   
Vision blurred  1/20 (5.00%) 
Gastrointestinal disorders   
Constipation  3/20 (15.00%) 
Dry Mouth  2/20 (10.00%) 
Flatulence  1/20 (5.00%) 
Nausea  2/20 (10.00%) 
General disorders   
Fatigue  1/20 (5.00%) 
Malaise  1/20 (5.00%) 
Metabolism and nutrition disorders   
Decreased appetitie  1/20 (5.00%) 
Nervous system disorders   
Headache  1/20 (5.00%) 
Dizziness  2/20 (10.00%) 
Sedation  2/20 (10.00%) 
Somnolence  1/20 (5.00%) 
Psychiatric disorders   
Anxiety  1/20 (5.00%) 
Depression  1/20 (5.00%) 
Libido decreased  1/20 (5.00%) 
Mental Status Changes  1/20 (5.00%) 
Restlesness  1/20 (5.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. James W Murrough
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-7574
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01882829     History of Changes
Other Study ID Numbers: GCO 13-0389
IF1463152
First Submitted: June 14, 2013
First Posted: June 20, 2013
Results First Submitted: April 5, 2017
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018