A Study in Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01185340
First received: August 18, 2010
Last updated: September 20, 2013
Last verified: September 2013

August 18, 2010
September 20, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
Change From Baseline to week 11 in Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01185340 on ClinicalTrials.gov Archive Site
  • Change from baseline to week 11 in Sheehan Disability Scale (SDS) Global Functional Impairment scale [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Fatigue Associated with Depression (FAsD) impact subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving a MADRS total score of less than or equal to 10 at week 11 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: through 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Hospital and Anxiety and Depression Scale (HADS) anxiety subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who have a greater than or equal to 50 percent improvement in the MADRS total score from baseline to week 11 [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in HADS depression subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in MADRS individual items [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Clinical Global Impressions of Severity (CGI-S) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in FAsD average score and experience subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Sheehan Disability Scale (SDS) items [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in the EuroQol Questionnaire-5 Dimension (EQ-5D) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in Arizona Sexual Experiences (ASEX) scale [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in blood pressure [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in pulse rate [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in Sheehan Disability Scale (SDS) Global Functional Impairment scale [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Fatigue Associated with Depression (FAsD) impact subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving a MADRS total score of less than or equal to 10 at week 11 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: through 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Hospital and Anxiety and Depression Scale (HADS) anxiety subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who have a greater than or equal to 50 percent improvement in the MADRS total score from baseline to week 11 [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in HADS depression subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in MADRS individual items [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Clinical Global Impressions of Severity (CGI-S) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in FAsD average score and experience subscale score [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in Sheehan Disability Scale (SDS) items [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 11 in the EuroQol Questionnaire-5 Dimension (EQ-5D) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in Arizona Sexual Experiences (ASEX) scale [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to week 11 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Baseline, 11 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study in Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: LY2216684
    12 mg to 18 mg Administered orally, once daily for 11 weeks
  • Drug: Placebo
    Administered orally, once daily for 11 weeks
  • Experimental: LY2216684
    Intervention: Drug: LY2216684
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Germany,   Sweden,   United Kingdom
 
NCT01185340
12183, H9P-MC-LNBR
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP