A Study of Flexible or Fixed Dose LLY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01187407
First received: August 20, 2010
Last updated: September 20, 2013
Last verified: September 2013

August 20, 2010
September 20, 2013
March 2011
August 2013   (final data collection date for primary outcome measure)
Change from baseline to week 11 in the 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 NCT01187407 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 participants achieving a MADRS total score of less than or equal 10 at week 11 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants achieving a MADRS total score of less than or equal 10 at 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 ]
  • Percent of participants 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 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 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 ]
  • Percent 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 of Flexible or Fixed Dose LLY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

The purpose of this study is to assess if LY2216684 (fixed 6 mg or flexible 12 mg to 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week, double-blind, acute adjunctive treatment phase.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder (MDD)
  • Drug: LY2216684
    Taken by mouth once daily
  • Drug: Placebo
    Taken by mouth once daily
  • Experimental: 6 mg Fixed-dose LY2216684
    6 mg for 11 weeks
    Intervention: Drug: LY2216684
  • Experimental: 12 or 18 mg Flexible-dose LY2216684
    6 mg for 3 days followed by 12 - 18 mg flexible-dose for up to 10.5 weeks
    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
1178
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Major Depressive Disorder (MDD)
  • Using a reliable method of birth control
  • Are taking an SSRI approved for MDD treatment within the patient's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
  • Have a partial response to SSRI treatment
  • Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
  • Reliable and able to keep all scheduled appointments

Exclusion Criteria:

  • Presence of another primary psychiatric illness:

    • Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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, post-traumatic stress disorder, generalized anxiety disorder, 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
  • Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, history of urinary hesitation 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
  • Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
  • Have received electroconvulsive therapy (ECT) in the past year
  • Enrollment in a clinical study for an investigational drug
  • Serious or unstable medical condition
  • History of seizure disorders
  • Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
  • Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Croatia,   Czech Republic,   Finland,   Japan,   Puerto Rico,   Slovakia
 
NCT01187407
12182, H9P-MC-LNBQ
Yes
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