Duloxetine for Chronic Depression: a Double-blind Study

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00360724
First received: August 3, 2006
Last updated: October 5, 2015
Last verified: October 2013
Results First Received: October 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dysthymic Disorder
Depressive Disorder NOS
Intervention: Drug: Duloxetine (Cymbalta)

  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
Subjects were recruited by advertisements, website postings, and from the hospital’s telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For patients on current ineffective psychotropic medication, washout was required, with >=7 days medication-free (>=28 days for fluoxetine). Concurrent sleep medication (zolpidem) was allowed for a maximum of 5 days during the study.

Reporting Groups
  Description
Duloxetine (Cymbalta) Duloxetine medication, ranging from 30 to 120 mg/day
Placebo Treatment placebo treatment, treatment with matching capsules of placebo

Participant Flow:   Overall Study
    Duloxetine (Cymbalta)     Placebo Treatment  
STARTED     33     32  
COMPLETED     29     28  
NOT COMPLETED     4     4  



  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
Duloxetine (Cymbalta) Duloxetine medication, ranging from 30 to 120 mg/day
Placebo Treatment placebo treatment: treatment with placebo capsules that match active medication capsules
Total Total of all reporting groups

Baseline Measures
    Duloxetine (Cymbalta)     Placebo Treatment     Total  
Number of Participants  
[units: participants]
  33     32     65  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     32     32     64  
>=65 years     1     0     1  
Age  
[units: years]
Mean (Standard Deviation)
  41  (11.7)     42.1  (11.4)     41.6  (11.2)  
Gender  
[units: participants]
     
Female     18     10     28  
Male     15     22     37  
Region of Enrollment  
[units: participants]
     
United States     33     32     65  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HDRS) - 24 Total Score   [ Time Frame: Week 10 ]

2.  Primary:   Hamilton Depression Rating Scale (HDRS) - 24 Total Score   [ Time Frame: Baseline ]

3.  Secondary:   Cornell Dysthymia Rating Scale (CDRS)   [ Time Frame: Week 10 ]

4.  Secondary:   Global Assessment of Functioning Scale (GAF)   [ Time Frame: Week 10 ]

5.  Secondary:   Beck Depression Inventory (BDI)   [ Time Frame: Week 10 ]

6.  Secondary:   Clinical Global Impressions Improvement(CGI-I)   [ Time Frame: 10 weeks ]

7.  Secondary:   Cornell Dysthymia Rating Scale (CDRS)   [ Time Frame: Baseline ]

8.  Secondary:   Beck Depression Inventory (BDI)   [ Time Frame: Baseline ]

9.  Secondary:   Global Assessment of Functioning Scale (GAF)   [ Time Frame: Baseline ]

10.  Secondary:   Magnetic Resonance Imaging, Anatomical   [ Time Frame: 10 weeks, 22 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2015   Safety Issue:   No

11.  Secondary:   Magnetic Resonance Imaging, Functional (fMRI)   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2015   Safety Issue:   No

12.  Secondary:   Magnetic Resonance Spectroscopic Imaging (MRSI)   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2015   Safety Issue:   No


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Hellerstein MD
Organization: NY State Psychiatric Institute
phone: 6467748000
e-mail: hellers@nyspi.columbia.edu


Publications of Results:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00360724     History of Changes
Other Study ID Numbers: # 4967/6363R
Study First Received: August 3, 2006
Results First Received: October 1, 2013
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board