A Study in Patients With Major Depressive Disorder Who Are Partial Responde... | Completed
A Study in Patients With Major Depr... | Completed
A Study in Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor

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Medical Conditions
  • Major Depressive Disorder
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01185340

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The primary objective of this study is to assess whether LY2216684 12 mg to 18 mg flexible dose once daily is superior to placebo Once Daily in the adjunctive treatment of patients with major depressive disorder (MDD) who are partial responders to their Selective Serotonin Reuptake Inhibitor Treatment (SSRI).
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : LY2216684, Drug : Placebo

Study Arm Groups : LY2216684, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Change From Baseline to week 11 in Montgomery-Asberg Depression Rating Scale (MADRS) total score; Baseline, 11 weeks
Secondary Outcome Measures
    Change from baseline to week 11 in Sheehan Disability Scale (SDS) Global Functional Impairment scale; Baseline, 11 weeks; Change from baseline to week 11 in Fatigue Associated with Depression (FAsD) impact subscale score; Baseline, 11 weeks; Percentage of patients achieving a MADRS total score of less than or equal to 10 at week 11; 11 weeks; Percentage of patients achieving a MADRS total score of less than or equal 10 at least 2 consecutive measurements including the patient's last measurement; through 11 weeks; Change from baseline to week 11 in Hospital and Anxiety and Depression Scale (HADS) anxiety subscale score; Baseline, 11 weeks; Percentage of patients who have a greater than or equal to 50 percent improvement in the MADRS total score from baseline to week 11; Baseline, 11 weeks; Change from baseline to week 11 in HADS depression subscale score; Baseline, 11 weeks; Change from baseline to week 11 in MADRS individual items; Baseline, 11 weeks; Change from baseline to week 11 in Clinical Global Impressions of Severity (CGI-S); Baseline, 11 weeks; Change from baseline to week 11 in FAsD average score and experience subscale score; Baseline, 11 weeks; Change from baseline to week 11 in Sheehan Disability Scale (SDS) items; Baseline, 11 weeks; Change from baseline to week 11 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF); Baseline, 11 weeks; Change from baseline to week 11 in the EuroQol Questionnaire-5 Dimension (EQ-5D); Baseline, 11 weeks; Percentage of treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS); Through 12 weeks; Change from baseline to week 11 in Arizona Sexual Experiences (ASEX) scale; Baseline, 11 weeks; Change from baseline to week 11 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ); Baseline, 11 weeks; Change from baseline to week 11 in blood pressure; Baseline, 11 weeks; Change from baseline to week 11 in pulse rate; Baseline, 11 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
793
Participant Inclusion Criteria
    Inclusion Criteria:

    - Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control

    - Are being treated with one of the following SSRIs: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, or fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose

    - Drug and dosage should be within the labeling guidelines for the specific country

    - Meet criteria for MDD, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) criteria

    - Meet criteria for partial response, as defined by investigator's opinion that patient has experienced a minimal clinically meaningful improvement with SSRI

    - Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score greater than or equal to 16 at screening

    - Have less than or equal to 75% improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ)

    Exclusion Criteria:

    - Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than major depression within 1 year of screening

    - 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)

    - Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder

    - Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine

    - Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol

    - Unstable medical conditions that contraindicate the use of LY2216684

    - Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, history of urinary hesitancy or retention

    - Use of excluded concomitant or psychotropic medication other than SSRI

    - Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment

    - History of treatment resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the patient has treatment-resistant depression

    - Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery

    - Have received electroconvulsive therapy (ECT) in the past year
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
CPSResearch
Glasgow
Scotland
G20 0XA
Chesterfield
Derbyshire
S40 4TF
Boehringer Ingelheim Investigational Site
Bexhill
TN40 1JJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Austria, Belgium, Germany, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomized Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 to 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
12183
Sponsor(s)
Eli Lilly and Company
Key Dates

Recruitment Start Date

Mar 2011

Recruitment End Date

Apr 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

18 Aug 2010

Date updated in source

20 Sep 2013