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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period from October 2013 to December 2015

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nuedexta (Dextromethorphan/Quinidine)

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


Participant Flow:   Overall Study
    Nuedexta (Dextromethorphan/Quinidine)
STARTED   20 
COMPLETED   14 
NOT COMPLETED   6 
Adverse Event                4 
Protocol Violation                1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nuedexta (Dextromethorphan/Quinidine) up to 45/10 mg every 12 hours x 8 weeks then once a day for 1 week

Baseline Measures
   Nuedexta (Dextromethorphan/Quinidine) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.4  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  45.0% 
Male      11  55.0% 
Montgomery-Asberg Depression Scale (MADRS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 32.5  (3.9) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.5  (0.5) 
[1] 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.


  Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale   [ Time Frame: At baseline and visit 6 (week 10) ]

2.  Secondary:   Quality of Life Enjoyment and Satisfaction Questionnaire Short Form   [ Time Frame: At baseline and Visit 6 (week 10) ]

3.  Secondary:   Range of Impaired Functioning Tool   [ Time Frame: At baseline and Visit 6 (week 10) ]

4.  Secondary:   Sheehan Disability Scale   [ Time Frame: At baseline and Visit 6 (week 10) ]

5.  Secondary:   Patient Rated Inventory of Side Effects (PRISE)   [ Time Frame: up to 12 weeks ]

6.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: up to 12 weeks ]

7.  Secondary:   Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)   [ Time Frame: up to 12 weeks ]

8.  Secondary:   Clinical Global Impression (CGI) Scale   [ Time Frame: up to 12 weeks ]

9.  Secondary:   Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)   [ Time Frame: At baseline and Visit 6 (week 10) ]

10.  Secondary:   HAM-A   [ Time Frame: Baseline and Week 10 ]

11.  Secondary:   Beck Scale for Suicidal Ideation (BSI)   [ Time Frame: Baseline and Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: james.murrough@mssm.edu


Publications of Results:

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