Major Depressive DisorderNCT00561509
Multi-Country Observational Study to Collect the Frequency of Sexual Dysfunction With Antidepressant Treatment, Either With SSRIs or Duals at 8 Weeks and 6 Months
An observational study of Major Depressive Disorder, run by Eli Lilly and Company at 57 sites in 13 countries.
Trial summary
In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SSRIs and Dual antidepressants
- How many people
- 1,626 participants
- Where
- 57 sitesin 13 countries
- Study dates
- Nov 2007to Jun 2009
- Phase
- Observational
- 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
Study population: The patient population will consist of sexually active male and female patients, 18 years or older with a primary diagnosis of MDD, for whom the treating clinician makes a decision to treat with a SSRI or SNRI antidepressant. Eligible patients must agree to participate in the collection of data, and must not present with treatment resistant depression or have sexual dysfunction at study entry.
Who may be able to join
- Meet the criteria for MDD, as defined by the ICD-10 or DSM-IV-TR
- Are at least moderately depressed (baseline CGI-S less than or equal to 4)
- Provide written consent to the release of their data after being informed about the study
- Present with an episode of MDD (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available SSRI or SNRI class of antidepressant in accordance with the investigator's decision for the management of the patient
- Have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
Who cannot join
- Meet any of the following criteria for sexual dysfunction at study entry (McGahuey et all. 2000: ASEX total score less than or equal 19 or ASEX score less than or equal to 5 on any item, or ASEX score less than or equal to 4 on any 3 items
- Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- Have a history of treatment resistant depression (TRD) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
- Have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
- Have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
Mexico14 sites
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Cancún
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Guadalajara
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León
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Mérida
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Mexicali
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Mexico City
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Monterrey
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Morelia
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Puebla City
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San Luis Potosí City
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Tijuana
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Torreón
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Victoria
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Villahermosa
Austria8 sites
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Innsbruck
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Jenbach
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Salzburg
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Spital/Drau
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Steyr
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Vienna
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Wels
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Wolfsberg
China8 sites
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Beijing
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Guangzhou
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Harbin
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Hong Kong
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Jinan
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Shanghai
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Suzhou
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Wuhan
Israel6 sites
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Bat Yam
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Beersheba
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Haifa
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Herzliya
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Hod HaSharon
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Ramat Gan
Saudi Arabia6 sites
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Dammam
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Jeddah
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Khamis Mushait
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Madinah
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Mecca
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Riyadh
Philippines4 sites
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Lucena City
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Makati
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Pasig
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Quezon City
Taiwan4 sites
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Hualien City
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Neihu Taipei
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Taichung
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Taipei
United Arab Emirates2 sites
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Abu Dhabi
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Dubai
Hong Kong1 site
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Pokfulam
Lebanon1 site
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Beirut
Malaysia1 site
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Kuala Lumpur
Singapore1 site
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Singapore
Thailand1 site
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Bangkok
About this study
Official title: A Prospective, Observational Study Comparing the Frequency of Treatment-Emergent Sexual Dysfunction Over 8 Weeks in Patients With Major Depressive Disorder Treated With Either Duloxetine Hydrochloride or a Selective Serotonin Reuptake Inhibitor Antidepressant and Evaluated Over 6 Months
In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation. Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their clinical discretion in the benefit of their patients and all clinical decisions will be recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction potentiality.
- Conditions
- Major Depressive Disorder
- Being tested
- SSRIs, Dual antidepressants
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIsDrug
Use within normal clinical practice
Dual antidepressantsDrug
Use within clinical practice
| Study group | Role | What they receive |
|---|---|---|
| A | SSRIs Receives: Drug: SSRIs | |
| B | Dual antidepressants Receives: Drug: Dual antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants
Measured: 8 weeks
Secondary outcomes (6)
Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants
Measured: 6 months
Disease severity
Measured: 6 months
Resource Utilization
Measured: 6 months
Quality of Life
Measured: 6 months
Treatment Compliance
Measured: 6 months
Identify factors related to sexual dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startNov 2007
- Study completionJun 2009
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 Major Depressive DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,626 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
- NCT00561509
- Sponsor's protocol ID
- 11539
- Other IDs
- F1J-MC-B019
- Status last verified
- Jul 2009
- First submitted
- 19 Nov 2007
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Duenas H, Lara C, Walton RJ, Granger RE, Dossenbach M, Raskin J. The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder. Int J Psychiatry Clin Pract. 2011 Sep;15(3):171-9. doi: 10.3109/13651501.2011.555820. Epub 2011 Feb 8.
PubMed 22121927
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study Comparing the Frequency of Treatment-Emergent Sexual Dysfunction Over 8 Weeks in Patients With Major Depressive Disorder Treated With Either Duloxetine Hydrochloride or a Selective Serotonin Reuptake Inhibitor Antidepressant and Evaluated Over 6 Months
- ClinicalTrials.gov ID
- NCT00561509
- Acronym / sponsor ID
- 11539
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,626 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Nov 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.
In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation. Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their clinical discretion in the benefit of their patients and all clinical decisions will be recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction potentiality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: SSRIsSSRIs |
| B | – | Drug: Dual antidepressantsDual antidepressants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will consist of sexually active male and female patients, 18 years or older with a primary diagnosis of MDD, for whom the treating clinician makes a decision to treat with a SSRI or SNRI antidepressant. Eligible patients must agree to participate in the collection of data, and must not present with treatment resistant depression or have sexual dysfunction at study entry.
Key inclusion criteria (5 listed)
- Meet the criteria for MDD, as defined by the ICD-10 or DSM-IV-TR
- Are at least moderately depressed (baseline CGI-S less than or equal to 4)
- Provide written consent to the release of their data after being informed about the study
- Present with an episode of MDD (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available SSRI or SNRI class of antidepressant in accordance with the investigator's decision for the management of the patient
- Have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
Key exclusion criteria (5 listed)
- Meet any of the following criteria for sexual dysfunction at study entry (McGahuey et all. 2000: ASEX total score less than or equal 19 or ASEX score less than or equal to 5 on any item, or ASEX score less than or equal to 4 on any 3 items
- Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- Have a history of treatment resistant depression (TRD) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
- Have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
- Have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
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 |
|---|---|---|
| SSRIsUse within normal clinical practice | Drug | A |
| Dual antidepressantsUse within clinical practice | Drug | B |
Primary outcome
Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants
Time frame: 8 weeks
6 secondary outcomes
Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants
Time frame: 6 months
Disease severity
Time frame: 6 months
Resource Utilization
Time frame: 6 months
Quality of Life
Time frame: 6 months
Treatment Compliance
Time frame: 6 months
Identify factors related to sexual dysfunction
Time frame: 6 months
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 15 Jul 2009.
- Derived from this study: PubMed 22121927Duenas H, Lara C, Walton RJ, Granger RE, Dossenbach M, Raskin J. The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder. Int J Psychiatry Clin Pract. 2011 Sep;15(3):171-9. doi: 10.3109/13651501.2011.555820. Epub 2011 Feb 8.
- 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
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Eli Lilly and Company at 57 sites in 13 countries.
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 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Mexico, Austria, China, Israel, Saudi Arabia and 8 more countries. 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.
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?
Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants (time frame: 8 weeks). 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 NCT00561509, 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 15 Jul 2009.