A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing

Lilly

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Fluoxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808612

B1Y-JE-HCLV (Other Identifier)

14595

Details and patient eligibility

About

The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in Japanese adult participants with Major Depressive Disorder (MDD).

Enrollment: 513 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient Japanese participants diagnosed with MDD
• Diagnosis of moderate or greater severity of MDD
• Agree to abstain from sexual activity or to use a reliable method of birth control
• Judged to be reliable (agree to keep appointments for clinic visits and to undergo all tests and examinations required by the protocol)

Exclusion criteria

• Have previously been exposed to fluoxetine (LY110140) for any indication in the past
• Significant suicidal risk
• Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
• Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
• Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks
• Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year
• Have had treatment with a Monoamine oxidase inhibitor (MAOI) within 14 days
• Need to use thioridazine or pimozide during the study
• Have previously enrolled, completed, or withdrawn from this study
• Have a positive urine drug screen for drugs with abuse potential
• Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
• Have a history of seizure disorder
• Have frequent or severe allergic reactions to multiple medications
• Have a serious or unstable medical illness or condition, or psychological condition
• Participants deemed ineligible by the investigator or sub-investigator for other reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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513 participants in 3 patient groups, including a placebo group

20 mg Fluoxetine

Experimental group

Description:

20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks

Treatment:

Drug: Fluoxetine

40 mg Fluoxetine

Experimental group

Description:

40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

Placebo (capsules) administered orally, once daily, for 6 weeks

Treatment:

Drug: Placebo