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- Conditions
- Major depressionMedDRA version: 14.0Level: LLTClassification code 10012387Term: Depression NOSSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2010-024632-42-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1249
[1] Meet criteria for primary MDD, as defined by DSM-IV-TR criteria, as determined by clinical assessment and confirmed by the MINI at Visit 1.
[2] Are adult male or female outpatients at least 18 years of age or older at the time of informed consent, who provide informed consent by signing the appropriate ICFs. Patients must be competent and able to give their own informed consent.
[3] Women of child-bearing potential may participate in the study. Females of childbearing potential must:
a)test negative for pregnancy at Visit 1 based on a serum pregnancy test, and
b)agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
Females of childbearing potential are those not surgically sterilized and between menarche and 1-year postmenopausal (2-years postmenopausal if <50 years of age).
Men participating agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
[4] Are being treated with 1 of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI for at least 8 weeks prior to Visit 2 and with at least the last 4 consecutive weeks at a stable optimized dose prior to Visit 2. The SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
[5] Meet criteria for partial response at Visit 1 and Visit 2, as defined by investigator?s opinion that the patient has experienced a minimally clinically meaningful improvement with the SSRI treatment.
[6] Have a GRID-HAMD17 total score ?16 at Visit 1.
[7] Have ? 75% improvement on the current SSRI at Visit 1, determined by the MGH-ATRQ-Modified Version.
[8] Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years.
[9] Have an education level and a degree of understanding such that the patient can communicate with the site study personnel.
[10] Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245
[11] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[12] Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for the conduct of the study).
[13] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this.
[14] Have previously completed or withdrawn from this study or any other study investigating LY2216684.
[15] Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than MDD that was considered the primary diagnosis within 1 year of Visit 1.
[16] Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), generalized anxiety disorder (GAD), and social phobia, but excluding specific phobias).
[17] Have a current or any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder.
[18] Have a history of substance abuse within the past 1 year (drug categories defined by DSM-IV-TR), and/or substance dependence within the past 1 year, not including caffeine and nicotine.
[19] Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
[20] In the judgment of the investigator, the patient meets criteria for treatment-resistant depression, defined as lack of response of the current episode of MDD to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks.
[21] Have a lifetime treatment history of vagal nerve stimulation, transcranial magnetic stimulation, or psychosurgery.
[22] Have received electroconvulsive therapy in the past year.
[23] Are women who are pregnant or breastfeeding.
[24] Are judged, in the opinion of the investigator, to be at serious risk of harm to self or others.
[25] Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant laboratory or ECG abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require significant intervention such as hospitalization or use of excluded medication during the course of the study.
[26] Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or a history of urinary hesitancy or retention.
[27] Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
[28] Have a history of any seizure disorder (other than febrile seizures).
[29] Have received treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 1 or have a potential need to use a monoamine oxidase inhibitor within 3 days after discontinuation from the study.
[30] Require psychotropic medication other
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