Combination Therapy in Patients With Depression

NCT00485862 | Completed Phase 4

• 2 other identifiers: 6066B4Z-MC-LYBN
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Test the hypothesis that augmentation of sertraline with atomoxetine for approximately 8 weeks will results in a statistically significantly greater symptom reduction in depressed patients compared with continued therapy with sertraline alone

Secondary Outcomes (8)

• To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in patients partially responsive or unresponsive to an adequate trial with sertraline monotherapy

• To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of partial responders to an adequate trial with sertraline monotherapy

• To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of nonresponders to an adequate trial with sertraline monotherapy

• To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of patients with less than a 50% reduction in baseline symptom severity after an adequate trial with sertraline monotherapy

• To compare the effects of the combination of sertraline plus atomoxetine with continued sertraline monotherapy on cognition in patients with no or partial response after an adequate trail with sertraline alone

Interventions

Atomoxetine Hydrochloride DRUG

Sertraline DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-IV criteria for major depression with a HAMD-17 rating scale score of at least 18 at visit 1
• Adult men or women, 18 years of age or older
• Must be able to swallow capsules
• Laboratory results must show no clinically significant abnormalities
• If suicidal ideation is present, the investigator should assess its severity and the potential need for other interventions and determine whether these are compatible with study participation

You may not qualify if:

• Have a documented history of Bipolar I or II disorder, or of psychosis.
• Have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control.
• Have a history of ADHD
• Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
• Are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seattle, Washington, United States

Location

Related Publications (1)

• Reimherr F, Amsterdam J, Dunner D, Adler L, Zhang S, Williams D, Marchant B, Michelson D, Nierenberg A, Schatzberg A, Feldman P. Genetic polymorphisms in the treatment of depression: speculations from an augmentation study using atomoxetine. Psychiatry Res. 2010 Jan 30;175(1-2):67-73. doi: 10.1016/j.psychres.2009.01.005. Epub 2009 Dec 6.

  PMID: 19969374 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Depression

Interventions

Atomoxetine Hydrochloride; Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2003
• Study Completion: January 1, 2005
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

US (1)