A Study in Adult Patients With Major Depressive Disorder
Tracking InformationStart Date ICMJE | December 2008 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: November 19, 2008) | The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00795821 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: November 19, 2008) | - Sheehan Disability Scale (SDS) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impressions of Severity Scale (CGI-Severity) [ Time Frame: 63 weeks ] [ Designated as safety issue: No ]
- The Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Euro-QoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Fatigue Associated With Depression (FAs-D) Patient Reported Outcome (PRO) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Brief Fatigue Inventory (BFI) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Visual Analogue Scale for Fatigue (VAS-F) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- Resource Utilization Form [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
- The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 63 weeks ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study in Adult Patients With Major Depressive Disorder |
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Official Title ICMJE | A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder |
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Brief Summary | The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with major depressive disorder. |
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Detailed Description | |
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Study Phase | Phase II, Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Depressive Disorder, Major |
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Intervention ICMJE | - Drug: LY2216684
Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks Other Name: LY2216684 - Drug: Placebo
Dose: 3 tablets QD for 62 weeks
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Study Arms / Comparison Groups | |
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Recruitment InformationEstimated Enrollment ICMJE | 376 |
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Estimated Completion Date | March 2011 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Adults age 18-65 years
- Meet criteria for MDD as defined by DSM-IV-TR criteria without psychotic features
- Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
- Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score >=18 at visit 1 and visit 2
- CGI-S score >=4 at visit 1 and visit 2
Exclusion Criteria: - Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
- Have previously completed or withdrawn from this study or any other study investigating LY2216684
- Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
- Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of visit 1
- Have an Axis II disorder which would interfere with compliance with the protocol
- Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia or other psychotic disorder
- Have a history of substance abuse within the past 1 year
- Women who are pregnant or breast-feeding
- Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgement of the investigator considered to have treatment resistant depression
- Patients who are judged to be at serious suicidal risk
- Have a serious or unstable medical illness
- Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
- Have received treatment with a MAOI within 14 days prior to visit 1
- Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
- Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
- Have a history of any seizure disorder (other than febrile seizures)
- Require psychotropic medication other than sedative/hypnotic medication for sleep
- Have a thyroid stimulating hormone (TSH ) level outside the established reference range.
- Are taking or have received treatment with any excluded medication within 7 days prior to visit 2
- Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
- A positive urine drug screen for any substance of abuse at visit 1
- Have initiate or discontinued hormone therapy within the previous 3 months prior to enrollment
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Gender | Both |
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Ages | 18 Years to 65 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
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Location Countries ICMJE | United States, Argentina, Finland, Poland, Russian Federation |
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Administrative InformationNCT ID ICMJE | NCT00795821 |
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Responsible Party | Chief Medical Officer, Eli Lilly |
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Study ID Numbers ICMJE | 11313, H9P-MC-LNBI |
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Study Sponsor ICMJE | Eli Lilly and Company |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | 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) | Eli Lilly and Company | |
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Information Provided By | Eli Lilly and Company |
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