A Safety Study in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01155661
First received: June 30, 2010
Last updated: April 30, 2013
Last verified: January 2013
  Purpose

The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in patients with major depressive disorder (MDD) who are partial responders to their SSRI treatment.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term, Open-Label, Safety Study of LY2216684 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:
  • The number of participants experiencing clinically significant effects [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through 55 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 54 week endpoint in Arizona Sexual Experiences (ASEX) scale [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 54 week endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 54 week endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual items [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Hospital Anxiety and Depression Scale (HADS) depression subscale score [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Fatigue Associated with Depression (FAsD) average score and subscale scores. [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants at 54 week endpoint who meet the response criteria for depressive symptoms [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants at 54 week endpoint who meet the remission criteria for depressive symptoms [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • The time when 25 percent of the patients meet response criteria of depressive symptoms [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Hospital Anxiety and Depression Scale (HADS) anxiety subscale score [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Sheehan Disability Scale (SDS) total score and subscores [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 54 week endpoint in Resource Utilization (RU) [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Discontinuation-emergent adverse events (DEAEs) [ Time Frame: 1 week after discontinuation ] [ Designated as safety issue: Yes ]
  • The time when 25 percent of the patients meet remission criteria of depressive symptoms [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of LY2216684 [ Time Frame: Weeks 2, 6, 8 ] [ Designated as safety issue: No ]
  • The number of participants experiencing clinically significant effects as a function of CYP2D6 genotype [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 54 week endpoint in blood pressure [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 54 week endpoint in pulse rate [ Time Frame: Baseline through 54 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684 Drug: LY2216684
12mg to 18 mg administered orally, once daily for 54 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults competent and able to give informed consent
  • 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
  • Patients who are being treated with one of the following SSRIs: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and 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 (Major Depressive Disorder), as defined by the Diagnostic and Statistical Manual, 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 Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
  • Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)
  • Meet all other inclusion criteria per protocol

Exclusion Criteria:

  • Presence of another primary psychiatric illnesses:

    • 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, 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
  • 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, 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
  • History of treatment resistant depression as shown by:

    • Have had 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 history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year
  • Meet any other exclusion criteria per protocol
  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: NCT01155661

  Show 48 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: NCT01155661     History of Changes
Other Study ID Numbers: 11318, H9P-MC-LNBO
Study First Received: June 30, 2010
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 02, 2014