Clinical trial NCT01485887: Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
Official title: A Open-label Long-term Extension Study To Evaluate The Safety And Efficacy Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Venlafaxine ER
long-term extension
Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
measure: Number of Participants With Clinical Significant Vital Changes
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
measure: Number of Participants With Clinical Significant Laboratory Tests Changes
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
measure: Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
measure: 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
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Secondary outcomes:
measure: Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point
timeFrame: 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
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point
timeFrame: 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
measure: Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
measure: Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point
timeFrame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44
Other outcomes:
Locations:
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
state: Chiba
city: Noda City
country: Japan
facility: Nakamoto Clinic
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Stress Care Yoshimura Clinic
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Hatakeyama Clinic
state: Fukuoka
city: Omuta
country: Japan
facility: Shiranui Hospital
state: Fukuoka
city: Hatsukaichi
country: Japan
facility: Fujikawa Clinic
state: Hiroshima
city: Ashiya
country: Japan
facility: Takahashi Psychiatric Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Ikeuchi Psycho Induced Internal Med.Clinic
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Kawasaki
country: Japan
facility: Medical Corporation Seishinkai Kishiro Mental Clinic
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Yutaka Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Tawara Clinic
state: Kanagawa
city: Yokosuka city
country: Japan
facility: Shioiri Mental Clinic
state: Kanagawa
city: Osakasayama-shi
country: Japan
facility: Shibamoto Clinic
state: Osaka
city: Adachi-ku
country: Japan
facility: Suzuki Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Omotesando Mental Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Kosei Nenkin Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Himorogi Psychiatric Institute
state: Tokyo
city: Fukuoka
country: Japan
facility: Tenjin Mental Clinic
city: Fukuoka
country: Japan
facility: Stress Care Yoshimura Clinic
city: Fukuoka
country: Japan
facility: Kuranari Psychiatry Clinic
city: Kanagawa
country: Japan
facility: Medical Corporation Toyokokai Tawara Clinic
city: Kyoto
country: Japan
facility: Sagaarashiyama-Tanaka Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.