Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

NCT01485887 | Completed Phase 3 Results

• 1 other identifier: B2411264
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 25

Brief Summary

This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Conditions

Major Depressive Disorder

Keywords

Venlafaxine ER; long-term extension; Japan

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

• Number of Participants With Clinical Significant Vital Changes

  Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP \>= 90 mmHg with change from the baseline \>= 10 mmHg; SBP \>= 140 mmHg with change from the baseline \>= 20 mmHg; PR \>= 100 bpm with change from the baseline \>= 15 bpm.

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

• Number of Participants With Clinical Significant Laboratory Tests Changes

  Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count \<0.8 x lower limit normal (LLN); Lymphocytes (%) \<0.8 x LLN; Eosinophils (%) \>1.2 x upper limit normal (ULN); Total Bilirubin \>1.5 x ULN; Alanine Aminotransferase (ALT) \>3.0 x ULN; Gamma glutamyl transferase (GGT) \>3.0 x ULN; Uric Acid \>1.2 x ULN; Cholesterol \>1.3 x ULN; Low density lipoprotein (LDL) cholesterol \>1.2 x ULN; Triglycerides \>1.3 x ULN; Glucose \>1.5 x ULN; Urine Glucose \[qualitative (Qual)\] \>=1; Urine Protein (Qual) \>=1; Urine Blood/Hemoglobin (Hgb) (Qual) \>=1.

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

• Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes

  Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)\> 450 millisecond (ms), \>480 ms, and \>500 ms respsctively, change from baseline in QTc, QTcB, and QTcF \>= 30 ms, and \>= 60 ms, respectively.

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

• Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

  C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

Secondary Outcomes (4)

• Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

• Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point

  Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

• Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point

  Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44

Study Arms (1)

Venlafaxine ER

EXPERIMENTAL

Drug: Venlafaxine ER

Interventions

Venlafaxine ER DRUG

Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration

Venlafaxine ER

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

You may not qualify if:

• Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
• Significant risk of suicide based on clinical judgment.
• Use of prohibited treatments

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (25)

Nippon Medical School Chiba Hokusoh Hospital

Inzai, Chiba, 270-1694, Japan

Location

Nakamoto Clinic

Noda, Chiba, 278-0033, Japan

Location

Stress Care Yoshimura Clinic

Fukuoka, Fukuoka, 810-0041, Japan

Location

Hatakeyama Clinic

Kitakyushu, Fukuoka, 802-0064, Japan

Location

Shiranui Hospital

Omuta, Fukuoka, 836-0004, Japan

Location

Fujikawa Clinic

Hatsukaichi, Hiroshima, 738-0023, Japan

Location

Takahashi Psychiatric Clinic

Ashiya, Hyōgo, 659-0093, Japan

Location

Ikeuchi Psycho Induced Internal Med.Clinic

Kobe, Hyōgo, 655-0037, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Medical Corporation Seishinkai Kishiro Mental Clinic

Kawasaki, Kanagawa, 214-0014, Japan

Location

Yutaka Clinic

Sagamihara-shi, Kanagawa, 252-0303, Japan

Location

Tawara Clinic

Yokohama, Kanagawa, 221-0835, Japan

Location

Shioiri Mental Clinic

Yokosuka, Kanagawa, 238-0042, Japan

Location

Shibamoto Clinic

Osakasayama-shi, Osaka, 589-0011, Japan

Location

Suzuki Hospital

Adachi-ku, Tokyo, 120-0033, Japan

Location

Sangenjaya Nakamura Mental Clinic

Setagaya-ku, Tokyo, 154-0004, Japan

Location

Omotesando Mental Clinic

Shibuya-ku, Tokyo, 150-0001, Japan

Location

Maynds Tower Mental Clinic

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Tokyo Kosei Nenkin Hospital

Shinjuku-ku, Tokyo, 162-8543, Japan

Location

Himorogi Psychiatric Institute

Toshima-ku, Tokyo, 170-0002, Japan

Location

Tenjin Mental Clinic

Fukuoka, 810-0004, Japan

Location

Stress Care Yoshimura Clinic

Fukuoka, 810-0041, Japan

Location

Kuranari Psychiatry Clinic

Fukuoka, 810-0801, Japan

Location

Medical Corporation Toyokokai Tawara Clinic

Kanagawa, 221-0835, Japan

Location

Sagaarashiyama-Tanaka Clinic

Kyoto, 616-8421, Japan

Location

Related Publications (1)

• 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.

  PMID: 26513202 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 6, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 28, 2021
• Results First Posted: May 15, 2015

Record last verified: 2021-01

Locations

JP (25)