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Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier:
NCT00398632
First received: November 10, 2006
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: April 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Depression
Intervention: Drug: Duloxetine

  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
No text entered.

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
Duloxetine

Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks


Participant Flow:   Overall Study
    Duloxetine
STARTED   6 
COMPLETED   4 [1] 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Lack of Efficacy                1 
[1] 2/6 subjects withdrew at end of week 6; 1 for lack of efficacy, 1 because of time constraints.



  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.
Adult patients taking an antidepressant drug and troubled by sexual side effects of the drug

Reporting Groups
  Description
Duloxetine Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks

Baseline Measures
   Duloxetine 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6 100.0% 
>=65 years      0   0.0% 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 44 [2] 
[1] Mean age only. The data were destroyed some years ago, and only the mean age was preserved.
[2] The data were destroyed some years ago, and only the mean age was preserved.
Gender 
[Units: Participants]
Count of Participants
 
Female      3  50.0% 
Male      3  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   6 
Antidepressant taken prior to duloxetine switch 
[Units: Participants]
 
venlafaxine   3 
citalopram   2 
fluoxetine   1 


  Outcome Measures

1.  Primary:   Global Clinical Impressions Improvement Score re Sexual Functioning   [ Time Frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6) ]

2.  Secondary:   Inventory of Depressive Symptomology   [ Time Frame: baseline and last visit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Open label trial, only six subjects enrolled, only 4 completed the trial


  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: Lorrin Koran, M.D., Professor of Psychiatry, Emeritus
Organization: Stanford University Medical Center, Department of Psychiatry
phone: 650 498 5035
e-mail: lkoran@stanford.edu



Responsible Party: Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier: NCT00398632     History of Changes
Other Study ID Numbers: 97143
Study First Received: November 10, 2006
Results First Received: April 19, 2015
Last Updated: December 14, 2016