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Org 24448 to Treat Major Depression

This study has been terminated.
(Terminated due to concerns about adverse events in separate study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00113022
First Posted: June 3, 2005
Last Update Posted: July 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
Results First Submitted: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Org 24448
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient with major depression who do not have a serious, unstable medical illness and are 21 to 55 years of age may be eligible. Candidates are screened with a psychiatric and medical history, diagnostic interview, physical examination, electrocardiogram, blood tests and, for women, a pregnancy test.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants are tapered off anti-depression drugs (and any other medications not allowed) over a 3-week period and then begin a 2-week drug-free period. During these 2 weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG indicates a seizure disorder are excluded from the study.

Reporting Groups
  Description
Org 24448 Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
Placebo Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.

Participant Flow:   Overall Study
    Org 24448   Placebo
STARTED   5   4 
COMPLETED   2   2 
NOT COMPLETED   3   2 



  Baseline Characteristics
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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
Org 24448 Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
Placebo Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
Total Total of all reporting groups

Baseline Measures
   Org 24448   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   5   4   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.20  (7.89)   40.00  (13.69)   39.00  (10.11) 
Gender 
[Units: Participants]
     
Female   3   3   6 
Male   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   5   4   9 


  Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Carlos Zarate
Organization: Experimental Therapeutics and Pathophysiology Branch, NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov


Publications:

Responsible Party: Carlos A. Zarate, M.D./National Institute of Mental Health, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00113022     History of Changes
Other Study ID Numbers: 050161
05-M-0161 ( Other Identifier: CNS-IRB, NIH )
First Submitted: June 2, 2005
First Posted: June 3, 2005
Results First Submitted: April 13, 2011
Results First Posted: July 6, 2012
Last Update Posted: July 13, 2012