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Principal Investigator


Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare (在職)

Division of Psychiatry

Division of Psychiatry

Taipei Medical University Hospital (在職)

Division of Psychiatry

Division of Psychiatry

更新時間：2023-09-19

李信謙 LEE, HSIN-CHIEN
  • Principal Investigator
  • Clinical Trial Experience (year) 17 years 9 個月

Recruiting Trial

11Cases

篩選

Developmental Phase

  • Phase I

  • Phase I/II

  • Phase II

  • Phase II/III

  • Phase III

  • Phase IV

  • Others

Trial Status

  • Not yet recruiting

  • Active

  • Completed

Recruitment Status

  • Not yet recruiting

  • Recruiting

  • Completed

  • Terminated

  • Stop recruiting

  • Suspended

  • Study ended

Trial scale

  • Multi-Regional Multi-Center

  • Taiwan Multiple Center

  • Taiwan Single Center

The expected start time interval of the test

-

Trial Applicant

  • Hospital/Foundation

  • Pharmaceutical/Biopharmaceutical company

  • Contract Research Organization

Important Roles

  • Asia Regional PI

  • Taiwan National PI

  • Chairman/Global PI

  • Steering Committee

  • Advisory board

  • None

Audit by Sponsors/CRO

  • Sponsors

  • CRO

  • None

Investigator-initiated trial(IIT)

  • Yes

Filters

李信謙

List

21Cases

2017-07-01 - 2022-12-20

Phase III

Completed
An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

  • Condition/Disease

    Treatment-resistant Depression

  • Test Drug

    ESKETAMINE

Participate Sites
7Sites

Recruiting4Sites

Terminated3Sites

劉嘉逸
Linkou Chang Gung Medical Foundation

Division of Psychiatry

李信謙
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Division of Psychiatry

2020-01-13 - 2022-06-07

Phase III

Completed
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

  • Condition/Disease

    Major Depressive Disorder

  • Test Drug

    ESKETAMINE

Participate Sites
10Sites

Recruiting10Sites

2022-10-01 - 2026-02-24

Phase IV

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
1Sites

Recruiting1Sites

2024-10-01 - 2026-12-31

Phase I

Active
A Phase I, Randomized, Double-blinded, Placebo- Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults

  • Condition/Disease

    Healthy Adults

  • Test Drug

    capsule

Participate Sites
1Sites

Recruiting1Sites

2020-08-16 - 2024-12-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Terminated7Sites

2023-01-01 - 2025-06-30

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Terminated4Sites

2025-11-01 - 2028-07-31

Phase III

Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)

  • Condition/Disease

    Adult subjects, ≥18 years of age, with a primary diagnosis of MDD who have had an IR to ≥1 oral antidepressant medication (including the subject’s current antidepressant treatment) in the current episode of depression.

  • Test Drug

    tablet

Participate Sites
4Sites

Not yet recruiting4Sites

2023-04-01 - 2026-01-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites

2025-07-01 - 2030-05-31

Phase III

Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)

  • Condition/Disease

    Depressive Disorder (MDD)

  • Test Drug

    tablet

Participate Sites
4Sites

Recruiting4Sites

2026-01-05 - 2028-09-13

Phase II

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
10Sites

Recruiting10Sites

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