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Desvenlafaxine vs. Placebo Treatment of Chronic Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537068
First Posted: February 22, 2012
Last Update Posted: September 11, 2017
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: June 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dysthymic Disorder
Dysthymia
Chronic Depressive Disorder
Interventions: Drug: Desvenlafaxine
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
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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
Desvenlafaxine

Serotonin–norepinephrine reuptake inhibitors (SNRIs) antidepressant drug

Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Placebo

Placebo treatment

Placebo: Matching placebo pills


Participant Flow:   Overall Study
    Desvenlafaxine   Placebo
STARTED   30   29 
COMPLETED   26   26 
NOT COMPLETED   4   3 
Lost to Follow-up                2                1 
Adverse Event                0                1 
Withdrawal by Subject                1                1 
Lack of Efficacy                1                0 



  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.
59 met inclusion criteria and started with study medication.

Reporting Groups
  Description
Desvenlafaxine

SNRI antidepressant drug

Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Placebo

Placebo treatment

Placebo: Matching placebo pills

Total Total of all reporting groups

Baseline Measures
   Desvenlafaxine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   29   59 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      29 100.0%      59 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.80  (14.18)   36.28  (11.65)   38.07  (13.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  63.3%      14  48.3%      33  55.9% 
Male      11  36.7%      15  51.7%      26  44.1% 
Region of Enrollment 
[Units: Participants]
     
United States   30   29   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Rating Scale for Depression (HDRS24)   [ Time Frame: Baseline ]

2.  Primary:   Hamilton Rating Scale for Depression (HDRS24)   [ Time Frame: Week 12 ]

3.  Secondary:   Response Rate   [ Time Frame: 12 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Hellerstein MD
Organization: NYSPI
phone: 646-774-8000
e-mail: desdesk@nyspi.columbia.edu


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01537068     History of Changes
Other Study ID Numbers: #6457 Pfizer-WS1895577
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: June 12, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017