- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485862
Combination Therapy in Patients With Depression
June 11, 2007 updated by: Eli Lilly and Company
Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy
The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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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
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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
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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
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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
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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
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To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in patients with no or partial response after an adequate trial with sertraline alone as measured by remission rates
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To test the hypotheses that patients homozygous or heterozygous for the short allele of serotonin transporter will be less responsive to sertraline than patients homozygous for the long allele
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To test the hypotheses that patients homozygous or heterozygous for the short allele of the serotonin transporter who have no or partial response to sertraline therapy will respond when atomoxetine is added to the treatment regimen
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
June 11, 2007
First Submitted That Met QC Criteria
June 11, 2007
First Posted (Estimate)
June 13, 2007
Study Record Updates
Last Update Posted (Estimate)
June 13, 2007
Last Update Submitted That Met QC Criteria
June 11, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Adrenergic Uptake Inhibitors
- Sertraline
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 6066
- B4Z-MC-LYBN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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