Duloxetine vs. Active Comparator in the Treatment of Patients With Depression

Phase 4CompletedNCT00071695

Eli Lilly and Company320 enrolled

Overview

How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

320

Conditions

Depression

Interventions

Duloxetine HydrochlorideDRUG

Venlafaxine Extended ReleaseDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be at least 18 years of age * Must be diagnosed with depression * Must sign informed consent * Women who can become pregnant must be using birth control Exclusion Criteria: * Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder * History of substance abuse or dependence in the last year * Patients who are suicidal * Frequent or severe allergic reactions with multiple medications

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

La Rochelle, France

Outcomes

Primary Outcomes

The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.

Secondary Outcomes

HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.

HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.

HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.

Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.

Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.

Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.

HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.