Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder

Recruiting in Palo Alto (17 mi)

+90 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Takeda

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.

Eligibility Criteria

Inclusion Criteria

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

The participant has recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI) V6.0.0.

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Treatment Details

Interventions

Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor)
Placebo (Pharmacotherapy)
vortioxetine (Lu AA21004) (Serotonin Receptor Agonist/Antagonist)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Vortioxetine (Lu AA21004) QDExperimental Treatment1 Intervention

Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.

Group II: Duloxetine QDActive Control1 Intervention

Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.

Group III: Placebo QDPlacebo Group1 Intervention

Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).