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Asenapine 5-20 mg daily for Depression

Phase 4

Waitlist Available

Led By John Beyer, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 4, 6 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 4, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 4, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in MADRS Total Score

Secondary study objectives

Clinical Remission Rate

Clinical Response Rate

Rates of Sustained Remission

+1 more

Side effects data

From 2014 Phase 4 trial • 46 Patients • NCT01670019

48%

Insomnia

43%

Excessive daytime sedation

22%

Oral/ Lingual dysaethesia

orthostasis faintness

100%

80%

60%

40%

20%

Study treatment Arm

Asenapine 5-20 mg Daily

Placebo 1-4 Tablets Daily

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Asenapine 5-20 mg dailyExperimental Treatment1 Intervention

Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability

Group II: Placebo 1-4 tablets dailyPlacebo Group1 Intervention

Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asenapine

FDA approved

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