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Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

Last updated on November 20, 2019

FOR MORE INFORMATION
Study Location
Narumi Himawari Clinic
Nagoya, Aichi, 458-0801 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatient status.

- A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical
Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode,
without psychotic features.

- Depressive symptoms for at least 90 days in single episode and for at least 28 days
in recurrent episode before the screening visit.

- A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS
total score at baseline is not over 25% from the screening visit.

- A QIDS16-J-SR score ≥16 at the screening and baseline visits.

- A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening
and baseline visits.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who concurrently have Axis II personality disorder or mental retardation
according to DSM-IV diagnostic criteria.

- Subjects who meet DSM-IV criteria for current or past history of Schizophrenia,
Paranoid Disorders, or any other Psychotic Disorders.

- Subjects who meet DSM-IV criteria for current or past history of Dementia.

- Subjects who meet DSM-IV criteria for current or past history of bipolar disorder,
Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).

- Subjects who meet DSM-IV criteria for current (within 12 months before the screening
visit) generalized anxiety disorder, panic disorder, or social anxiety disorder
considered by the investigator to be primary (causing a higher degree of distress or
impairment than MDD).

- Subjects with a first degree relative with bipolar disorder.

- Subjects who are actively suicidal.

- History of non-responsive to 2 antidepressant treatment (at least 6-week usage for
each) for the past or current episodes.

- History of Electroconvulsive therapy (ECT) at any time in the past.

- History of chronic treatment with benzodiazepines for longer than 6 months before the
screening visit (Excluding subjects who have taken PRN benzodiazepine use, times/week).

- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, or any other medical condition that in the
investigator's judgment, will substantially increase the risk associated with the
subject's participation in and completion of, the study.

- Known presence of raised intraocular pressure or history or presence of narrow angle
glaucoma.

- Myocardial infarction within 180 days of the screening visit.

- Clinically important abnormalities, as determined by the investigator, on screening
physical examination, electrocardiogram (ECG) or laboratory tests.

- Use of prohibited treatments

NCT01441440
Pfizer
Completed
Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder
Brief SummaryThis is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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: venlafaxine ER 75 mg/day (fixed dose)
    Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration
  • Drug: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
    Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration
  • Drug: Placebo
    Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration
Study Arms  ICMJE
  • Experimental: venlafaxine ER 75 mg/day (fixed dose)
    Intervention: Drug: venlafaxine ER 75 mg/day (fixed dose)
  • Experimental: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
    Intervention: Drug: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Higuchi T, Kamijima K, Nakagome K, Itamura R, Asami Y, Kuribayashi K, Imaeda T. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan. Int Clin Psychopharmacol. 2016 Jan;31(1):8-19. doi: 10.1097/YIC.0000000000000105.


*   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: March 27, 2014)
538
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2011)
534
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient status.
  • A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
  • Depressive symptoms for at least 90 days in single episode and for at least 28 days in recurrent episode before the screening visit.
  • A MADRS total score ?26 at the screening and baseline visits. And change of MADRS total score at baseline is not over 25% from the screening visit.
  • A QIDS16-J-SR score ?16 at the screening and baseline visits.
  • A score ?4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline visits.

Exclusion Criteria:

  • Subjects who concurrently have Axis II personality disorder or mental retardation according to DSM-IV diagnostic criteria.
  • Subjects who meet DSM-IV criteria for current or past history of Schizophrenia, Paranoid Disorders, or any other Psychotic Disorders.
  • Subjects who meet DSM-IV criteria for current or past history of Dementia.
  • Subjects who meet DSM-IV criteria for current or past history of bipolar disorder, Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).
  • Subjects who meet DSM-IV criteria for current (within 12 months before the screening visit) generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
  • Subjects with a first degree relative with bipolar disorder.
  • Subjects who are actively suicidal.
  • History of non-responsive to 2 antidepressant treatment (at least 6-week usage for each) for the past or current episodes.
  • History of Electroconvulsive therapy (ECT) at any time in the past.
  • History of chronic treatment with benzodiazepines for longer than 6 months before the screening visit (Excluding subjects who have taken PRN benzodiazepine use, < 3 times/week).
  • Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study.
  • Known presence of raised intraocular pressure or history or presence of narrow angle glaucoma.
  • Myocardial infarction within 180 days of the screening visit.
  • Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG) or laboratory tests.
  • Use of prohibited treatments
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01441440
Other Study ID Numbers  ICMJE B2411263
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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