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Proposal 1819

Title of the Proposed Research

INDIVIDUAL PARTICIPANT DATA META-ANALYSIS OF ANTIDEPRESSANT TRIALS FOR MAJOR DEPRESSION IN JAPAN

Lead Researcher

Shigeto Yamawaki

Affiliation

Strategic Research Program for Brain Sciences by Ministry of Education, Culture, Sports, Science and Technology, Japan
Japan Agency for Medical Research and Development
Japanese Society of Neuropsychopharmacology

Funding Source

None

Potential Conflicts of Interest

Summary for all Researchers and Statistician
SY has received lecture fee from Mochida Pharmaceutical, Japan Eli Lilly, Pfizer, MSD, Sumitomo Dainippon Pharma, Meiji Seika Pharma, Eisai Pharmaceutical. He has received consultation fee from Lundbeck Japan, Takeda Pharmaceuticals and Brain Science Foundation.JI has received presentation and writing fees: Otsuka Pharmaceutical Co., Ltd.; Sumitomo Dainippon Pharma Co., Ltd.; Shionogi & Co., Ltd.; Takeda Pharmaceutical Company Limited; Eli Lilly Japan K.K.; Novartis Pharma K.K.; Pfizer Japan Inc.; Janssen Pharmaceutical K.K.; and MSD K.K, and scholarship grants: Sumitomo Dainippon Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited.TAF has received lecture fees from Eli Lilly, Janssen, Meiji, MSD, Otsuka, Pfizer and Tanabe-Mitsubishi, and consultancy fees from Sekisui Chemicals and Takeda Science Foundation. He has received royalties from Igaku-Shoin and Nihon Bunka Kagaku-sha publishers. He has received research support from Mochida and Tanabe-Mitsubishi.ST has received lecture fee from Kobe City, Astra-Zeneca, Taiho Pharmaceutical, and Ono Pharmaceutical. He has received consultation fee from Pharmaceuticals and Medical Devices Agency, DeNA Life Science, and CanBus. He has received outsourcing fee from Public Health Research Foundation, Japan Breast Cancer Research Group, Satt, and Asahi Kasei Pharma. His wife has engaged in a research project of Bayer Yakuhin.NW has also received royalties from Sogensha, Paquet and Akatsuki. HN has received lecture and writing fee from Iwanami Shoten, Kyowa Kirin, Life Science Publishing, Yodosha, Yakuji Nippo and the Japanese Society of Clinical Pharmacology and Therapeutics. He has received consultation fee Kyowa Kirin. He has received grants from GlaxoSmithKline.

Data Sharing Agreement Date

18 May 2017

Lay Summary

CINP (The International College of Neuropsychopharmacology) and JSNP (Japanese Society of Neuropsychopharmacology) have set up a public private partnership (PPP) taskforce to promote drug developments in the central nervous system domains in Japan. Within this larger framework, we have started a project to utilize the existing clinical trial data (individual participant data) from placebo-controlled antidepressant trials for depression conducted in Japan to explore new leads in CNS drug development.

We are aiming at conducting the analyses as detailed in the statistical analysis plan with individual participant data from eight Phase II or III clinical trials of venlafaxine ER, bupropion SR, paroxetine CR, escitalopram (2 trials), desvenlafaxine, duloxetine and mirtazapine conducted in Japan.

The main purposes of the present study are two:
A) Identify subgroups of patients that show greater differentiation between antidepressants and placebo, in order to contribute to the planning of more efficient trials in the future
B) Identify subgroups of patients that show smaller differentiation between antidepressants and placebo, in order to identify unmet medical needs and we will conduct the independent participant data meta-analyses to address these questions. The findings will be communicated to the public via scientific publications.

Study Data Provided

GSK-AK1113351: Study AK1113351, a fixed dose study of 323U66 SR in the treatment of Major Depressive Disorder (MDD) - a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study
GSK-PCR112810: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.