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
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2216684
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 793
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684 Drug: LY2216684
12 mg to 18 mg Administered orally, once daily for 11 weeks
Placebo Comparator: Placebo Drug: Placebo
Administered orally, once daily for 11 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185340

  Show 49 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01185340     History of Changes
Other Study ID Numbers: 12183, H9P-MC-LNBR
Study First Received: August 18, 2010
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Depression
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on October 20, 2014