A Study for Patients With Major Depression

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00420004
First received: January 5, 2007
Last updated: October 5, 2009
Last verified: October 2009

January 5, 2007
October 5, 2009
December 2006
March 2008   (final data collection date for primary outcome measure)
17-item Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
Test the hypothesis that LY2216684 will result in statistically significant symptom reduction in patients with major depressive disorder compared with placebo.
Complete list of historical versions of study NCT00420004 on ClinicalTrials.gov Archive Site
  • Maier-Philipp Subscale of the HAMD-17 [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Response and Remission Rates [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Improvement [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • SF-36 Health Survey [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Quick Inventory of Depressive Symptomatology [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Beck Scale for Suicide Ideation [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Modified Overt Aggression Scale [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Cognitive Assessment Battery [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Arizona Sexual Experiences Scale [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Insomnia Severity Index [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • 21-item Hamilton Depression Rating Scale [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]
  • To compare the efficacy of LY2216684 with placebo, as measured by the change from baseline in global clinical improvement.
  • To compare the efficacy of LY2216684 with placebo, as measured by the response and remission rates and time course of response and remission.
  • To compare the efficacy of LY2216684 with placebo, as measured by the change from baseline in anxiety symptoms.
  • To compare the impact of LY2216684 with placebo on quality of life and general well being.
  • To compare the efficacy of LY2216684 with placebo treatment on suicidal ideation.
  • To compare the efficacy of LY2216684 with placebo, as measured by the change from baseline to endpoint in a self-rated depression inventory.
  • To compare LY2216684 with placebo treatment on emergence of impulsivity or aggression.
  • To compare LY2216684 with placebo treatment on sexual functioning.
  • To compare the efficacy of LY2216684 with placebo treatment on a cognitive assessment battery.
  • To compare the impact of LY2216684 with placebo on sleep.
  • To compare the efficacy of an active comparator with Placebo on all endpoints as an internal validity of the study.
  • To compare the safety and tolerability of LY2216684 relative to the safety of active comparator, and placebo therapies.
  • To assess the pharmacokinetics of LY2216684.
Not Provided
Not Provided
 
A Study for Patients With Major Depression
A Study of the Effects of LY2216684, a Selective Norepinephrine Reuptake Inhibitor (NERI), in the Treatment of Major Depression

This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.

Not Provided
Interventional
Phase 2
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
  • Drug: LY2216684
    3 mg - 12 mg once daily oral dose (tablets) with flexible titration for 8 weeks.
  • Drug: Placebo
    tablet and capsule equivalents to LY2216684 and escitalopram taken once daily for 8 weeks
  • Drug: escitalopram
    10 mg or 20 mg once daily oral dose (capsules) with flexible titration for 8 weeks
  • Experimental: 1
    LY2216684
    Intervention: Drug: LY2216684
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Placebo
  • Active Comparator: 3
    escitalopram
    Intervention: Drug: escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
470
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet criteria for major depressive disorder (MDD) without psychotic features.
  • Have education level and a degree of understanding such that the patient can communicate with the site study personnel.
  • Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.

Exclusion Criteria:

  • Have had any additional, ongoing psychiatric condition other than major depression or dysthymia that was considered the primary diagnosis within 6 months of Visit 1.
  • Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a factitious disorder.
  • Are judged to be at high risk for imminently harming themselves or others.
  • Have a serious medical illness, including any cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, or clinically significant laboratory or ECG abnormality. Clinically significant lab abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require intervention.
  • Have any diagnosed medical condition which could be exacerbated by treatment with LY2216684 including hypertension, increased heart rate, arrhythmias, heart disease, narrow angle glaucoma, or urinary hesitancy.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Romania
 
NCT00420004
11174, H9P-MC-LNBD
No
Chief Medical Officer, Eli Lilly
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
October 2009

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