A Study for Participants With Major Depression

Lilly

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: LY2216684; Drug: Escitalopram; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420004

11174

H9P-MC-LNBD (Other Identifier)

Details and patient eligibility

About

This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.

Enrollment: 469 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet criteria for major depressive disorder (MDD) without psychotic features.
• Have education level and a degree of understanding such that the participant can communicate with the site study personnel.
• Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.

Exclusion criteria

• Have had any additional, ongoing psychiatric condition other than major depression or dysthymia that was considered the primary diagnosis within 6 months of the first study visit.
• Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a factitious disorder.
• Are judged to be at high risk for imminently harming themselves or others.
• Have a serious medical illness, including any cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality. Clinically significant lab abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require intervention.
• Have any diagnosed medical condition which could be exacerbated by treatment with LY2216684, including hypertension, increased heart rate, arrhythmias, heart disease, narrow angle glaucoma, or urinary hesitancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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469 participants in 3 patient groups, including a placebo group

LY2216684

Experimental group

Description:

LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks. For the first week of treatment, participants received a starting dose of 3 mg/day. Then, based on tolerability, for the next 7 weeks, the dose could remain at 3 mg/day; it could be increased 3 mg at a time (scheduled visit) to a maximum dose of 12 mg/day; or it could be decreased 3 mg at any time (scheduled or unscheduled visits) to a minimum dose of 3 mg/day. All participants were required to take an equal number of tablets (2) and capsules (2) per day. Therefore, participants on 3 mg/day and 6 mg/day of LY2216684 also received 1 LY2216684-matching placebo tablet + 2 escitalopram-matching placebo capsules. Participants on 9 mg/day and 12 mg/day of LY2216684 also received 2 escitalopram-matching placebo capsules.

Treatment:

Drug: LY2216684

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks.

Treatment:

Drug: Placebo

Escitalopram

Active Comparator group

Description:

Escitalopram: flexible dose of 10 or 20 milligram (mg), capsules, administered orally, once daily for 8 weeks. For the first week of treatment, participants received a starting dose of 10 mg/day. Then, based on tolerability, for the next 7 weeks, the dose could remain at 10 mg/day; it could be increased up to a maximum dose of 20 mg/day; or it could be decreased back to 10 mg/day. All participants were required to take an equal number of tablets (2) and capsules (2) per day. Therefore, participants on 10 mg/day of escitalopram also received 1 escitalopram-matching placebo capsule + 2 LY2216684-matching placebo tablets. Participants on 20 mg/day of escitalopram also received 2 LY2216684-matching placebo tablets.

Treatment:

Drug: Escitalopram

Drug: Placebo