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Desvenlafaxine vs. Placebo Treatment of Chronic Depression

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ClinicalTrials.gov Identifier: NCT01537068
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
New York State Psychiatric Institute

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
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desvenlafaxine Placebo
Hide Arm/Group Description

Serotonin–norepinephrine reuptake inhibitors (SNRIs) antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

Period Title: Overall Study
Started 30 29
Completed 26 26
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             2             1
Adverse Event             0             1
Withdrawal by Subject             1             1
Lack of Efficacy             1             0
Arm/Group Title Desvenlafaxine Placebo Total
Hide Arm/Group Description

SNRI antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

Total of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
59 met inclusion criteria and started with study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 59 participants
39.80  (14.18) 36.28  (11.65) 38.07  (13.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
19
  63.3%
14
  48.3%
33
  55.9%
Male
11
  36.7%
15
  51.7%
26
  44.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 59 participants
30 29 59
1.Primary Outcome
Title Hamilton Rating Scale for Depression (HDRS24)
Hide Description HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desvenlafaxine Placebo
Hide Arm/Group Description:

SNRI antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.63  (3.39) 14.21  (3.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures of ANOVA
Method of Estimation Estimation Parameter Test of Within-subjects effects
Estimated Value 2.95
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hamilton Rating Scale for Depression (HDRS24)
Hide Description HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desvenlafaxine Placebo
Hide Arm/Group Description:

SNRI antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.53  (3.98) 8.24  (4.86)
3.Secondary Outcome
Title Response Rate
Hide Description Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desvenlafaxine Placebo
Hide Arm/Group Description:

SNRI antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

Overall Number of Participants Analyzed 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
16
  61.5%
7
  26.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi-squared
Estimated Value 6.32
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desvenlafaxine Placebo
Hide Arm/Group Description

SNRI antidepressant drug

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

Placebo treatment

Placebo: Matching placebo pills

All-Cause Mortality
Desvenlafaxine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      1/29 (3.45%)    
Nervous system disorders     
Seizure [1]  0/30 (0.00%)  0 1/29 (3.45%)  1
[1]
Patient was treated with placebo and this was an pre-existing condition.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desvenlafaxine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/30 (96.67%)      19/29 (65.52%)    
Gastrointestinal disorders     
Dry Mouth  7/30 (23.33%)  7 2/29 (6.90%)  2
General disorders     
Headache  9/30 (30.00%)  9 4/29 (13.79%)  4
Nausea  9/30 (30.00%)  9 3/29 (10.34%)  3
Agitation  5/30 (16.67%)  5 0/29 (0.00%)  0
Dizziness  5/30 (16.67%)  5 0/29 (0.00%)  0
Sweating  5/30 (16.67%)  5 2/29 (6.90%)  2
Metabolism and nutrition disorders     
Decreased sleep  10/30 (33.33%)  10 4/29 (13.79%)  4
Daytime Sleepiness  9/30 (30.00%)  9 5/29 (17.24%)  5
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
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