Clinical trial NCT00071695: Duloxetine vs. Active Comparator in the Treatment of Patients With Depression
Official title: Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-10-30
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
measure: 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.
measure: HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.
measure: Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.
measure: Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.
measure: Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.
measure: 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.
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.