Depressive SymptomsPhase 4NCT00485862
Combination Therapy in Patients With Depression
A Phase 4 study testing Atomoxetine Hydrochloride and Sertraline in people with Depressive Symptoms, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Atomoxetine Hydrochloride and Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
Official title: 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.
- Conditions
- Depressive Symptoms
- Being tested
- Atomoxetine Hydrochloride, Sertraline, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine HydrochlorideDrug
SertralineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJun 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485862
- Sponsor's protocol ID
- 6066
- Other IDs
- B4Z-MC-LYBN
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
Publications
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.
PubMed 19969374
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy
- ClinicalTrials.gov ID
- NCT00485862
- Acronym / sponsor ID
- 6066
- Conditions
- Depressive Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine Hydrochloride | Drug | – |
| Sertraline | Drug | – |
| Placebo | Drug | – |
Primary outcome
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
8 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
- Derived from this study: PubMed 19969374Reimherr 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine Hydrochloride and Sertraline in people with Depressive Symptoms, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00485862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2007.