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Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01056289
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : February 17, 2012
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 22, 2010
First Posted Date  ICMJE January 26, 2010
Results First Submitted Date  ICMJE January 31, 2012
Results First Posted Date  ICMJE February 17, 2012
Last Update Posted Date February 28, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase [ Time Frame: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182) ]
Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
Discontinuation-Emergent Signs and Symptoms (DESS) scale [ Time Frame: The first two weeks of the double-blind phase ]
Change History Complete list of historical versions of study NCT01056289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase [ Time Frame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) ]
    Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.
  • Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms [ Time Frame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) ]
    Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
Incidence of taper/post-study adverse events and the percentage of subjects unable to complete the double-blind phase due to discontinuation symptoms [ Time Frame: 4 weeks of double-blind phase ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
Official Title  ICMJE A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation
Brief Summary Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
    DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
  • Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
    DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
  • Drug: Placebo
    DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
Study Arms  ICMJE
  • Active Comparator: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
  • Active Comparator: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Ninan PT, Musgnung J, Messig M, Buckley G, Guico-Pabia CJ, Ramey TS. Incidence and Timing of Taper/Posttherapy-Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 5;17(1). doi: 10.4088/PCC.14m01715. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2011)
480
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2010)
450
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary Diagnosis of Major Depressive Disorder
  • Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline

Exclusion Criteria:

  • Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
  • Potentially violent to others or is at significant risk for suicide
  • History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
  • Known presence of raised intraocular pressure or history of narrow angle glaucoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01056289
Other Study ID Numbers  ICMJE 3151A1-4437
B2061010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP