Duloxetine Versus Placebo in the Long-Term Treatment of Patients with Late-Life Major Depression - HMFA
- Conditions
- Major Depressive Disorder in elderly patientsMedDRA version: 9.1Level: LLTClassification code 10012378Term: Depression
- Registration Number
- EUCTR2008-001829-33-FR
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
[1] Are male or female outpatients at least 65 years of age.
[2] Sign the informed consent document.
[3] Meet criteria for major depression as defined by the Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition Text Revision
(DSM-IV-TR) (American Psychiatric Association. 1994).
[4] Have a MADRS total score of at least 20 at Visits 1 and 2.
[5] Have a MMSE score of at least 20 at Visit 1.
[6] Have had at least one prior episode of MDD as defined by DMS-IVTR.
[7] Have a degree of understanding such that the patient can communicate
intelligibly with the investigator and study coordinator.
[8] Are judged to be reliable and agree to keep all appointments for clinic
visits, tests, and procedures required by the protocol (including use of
an automated voice response system) and are able to swallow all
required medication without opening or crushing.
[9] Agree not to participate in any other research trial or study while
enrolled in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[10] Are investigator site personnel directly affiliated with the study, or are
immediate family of investigator site personnel directly affiliated with
the study.
[11] Are employed by Lilly
[12] Have received treatment with a drug within the last 30 days that has
not received regulatory approval at the time of study entry.
[13] Are persons who have previously completed or withdrawn from this
study or any other study investigating duloxetine for the treatment of
depression.
[14] Have any prior history of bipolar disorder, panic disorder, psychosis,
schizophrenia, or obsessive-compulsive disorder.
[15] Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
[16] Have moderate to severe dementia.
[17] Have a mental retardation diagnosis or the presence of any other Axis
II disorder that, in the judgment of the investigator would interfere
with the study compliance.
[18] Patients judged clinically to be at serious suicidal risk in the opinion of
the investigator.
[19] Have a history of substance abuse or dependence within the past 6
months (drug categories defined in the DSM-IV), excluding nicotine
and caffeine.
[20] Have a positive urine drug screen for any substances of abuse.
[21] Lack of response of the current episode of major depression to two or
more adequate courses of antidepressant therapy with an adequate
medication trial defined as a score of > 3 on the Antidepressant
Treatment History Form. This tool is provided to sites with the
protocol.
[22] Have a history of a lack of response, at any time, to an adequate trial
of duloxetine for the treatment of MDD (defined as treatment with at
least 60mg/day of duloxetine for a minimum of 4 weeks).
[23] Have a serious medical illness or clinically significant laboratory
abnormality that is not stabilized or is anticipated to require
hospitalization within 6 months, in the opinion of the investigator.
[24] At Visit 1 an ALT, AST, or GGT >3 times upper limit of normal
(ULN), based on Study Central Laboratory reference ranges.
[25] Have been diagnosed with an acute liver injury or
severe cirrhosis
[26] Have a prior renal transplant, current renal dialysis, or serum
creatinine laboratory value > 1.5 times upper limit of normal (ULN)
[27] Are taking any excluded medications within 7 days prior to Visit 2 with the exception of fluoxetine which cannot be taken within 30 days prior to Visit 2.
[28] Treatment with a monoamine oxidase inhibitor (MAOI) within 14
days prior to Visit 2 or have the potential need to use an MAOI during
the study or within 5 days of discontinuation of study drug.
[29] Have frequent and/or severe allergic reactions to multiple medications,
or known allergic reactions to any of the study drugs.
[30] Known hypersensitivity to duloxetine or any of the inactive
ingredients.
[31] Patients with uncontrolled narrow-angle glaucoma.
[32] Have abnormal thyroid-stimulating hormone (TSH) concentration.
[33] Have discontinued hormone replacement therapy within the previous 3
months.
[34] Have had electroconvulsive therapy (ECT) or transcranial magnetic
stimulation (TMS) within the past year.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method