Clinical trial • Phase III • Psychiatry

Clinical trial in Major depressive disorder | Incomplete Response - Major Depressive Disorder (IR-MDD)

Phase III trial for Major depressive disorder | Incomplete Response - Major Depressive Disorder (IR-MDD). 72 participants.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Major depressive disorder | Incomplete Response - Major Depressive Disorder (IR-MDD)
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
22-08-2025
First CTIS Authorization Date
31-10-2025

Trial design

Phase III trial across 1 site in Netherlands.

Target Sample Size
72

Eligibility

Recruits 72 No vulnerable populations selected; consent/assent handling not specified..

Vulnerable Population
No vulnerable populations selected; consent/assent handling not specified.

Recruitment

Planned Sample Size
72
Recruitment Window Months
9

Geography

Total Number Of Sites
1
Total Number Of Participants
72

Netherlands

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
203
Number Of Sites
1
Number Of Participants
72

Sites

Site Name
Centre for Human Drug Research
Department Name
Psychiatry
Contact Person Name
Gabriel Jacobs
Contact Person Email
clintrials@chdr.nl

Sponsor

Primary sponsor

Full Name
Otsuka Pharmaceutical Development & Commercialization Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

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