ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
- HAM-D 17 total score of ≥20.
- Patient who meets DSM-5 criteria of the following disorders for current or past
history.
Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders
Substance use disorders (exclusive of tobacco and caffeine)
- Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS)
within 1 year before start of screening phase.
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| Descriptive Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Study of MD-120 in Patients With Depression | ||||||||
| Official Title ICMJE | A Placebo-controlled Study of MD-120 in Patients With Depression | ||||||||
| Brief Summary | The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression. | ||||||||
| Detailed Description | Not 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 |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 594 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)
| ||||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Japan | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04345471 | ||||||||
| Other Study ID Numbers ICMJE | MD120101 JapicCTI-205252 ( Registry Identifier: JapicCTI ) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mochida Pharmaceutical Company, Ltd. | ||||||||
| Study Sponsor ICMJE | Mochida Pharmaceutical Company, Ltd. | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
| ||||||||
| PRS Account | Mochida Pharmaceutical Company, Ltd. | ||||||||
| Verification Date | March 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||