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
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2216684
Drug: Placebo
Drug: escitalopram
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Effects of LY2216684, a Selective Norepinephrine Reuptake Inhibitor (NERI), in the Treatment of Major Depression

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 17-item Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 470
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LY2216684
Drug: LY2216684
3 mg - 12 mg once daily oral dose (tablets) with flexible titration for 8 weeks.
Placebo Comparator: 2
placebo
Drug: Placebo
tablet and capsule equivalents to LY2216684 and escitalopram taken once daily for 8 weeks
Active Comparator: 3
escitalopram
Drug: escitalopram
10 mg or 20 mg once daily oral dose (capsules) with flexible titration for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00420004

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orlando, Florida, United States, 32806
United States, Kansas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Prairie Village, Kansas, United States, 66206
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Allentown, Pennsylvania, United States, 18104
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Media, Pennsylvania, United States, 19063
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucharest, Romania, 73120
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cluj-Napoca, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lasi, Romania, 6600
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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00420004     History of Changes
Other Study ID Numbers: 11174, H9P-MC-LNBD
Study First Received: January 5, 2007
Last Updated: October 5, 2009
Health Authority: India: Ministry of Health
United States: Food and Drug Administration
Romania: Ministry of Public Health
Mexico: Ministry of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014