Clinical trial NCT00420004: A Study for Participants With Major Depression
Official title: A Study of the Effects of LY2216684, a Selective Norepinephrine Reuptake Inhibitor (NERI), in the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Meet criteria for major depressive disorder (MDD) without psychotic features.
* Have education level and a degree of understanding such that the participant 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 the first study visit.
* 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 electrocardiogram (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.

Primary outcomes:
measure: Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Baseline, Week 8
measure: Response and Remission Rates
timeFrame: Baseline, up to Week 8
measure: Clinical Global Impression of Improvement Score at Week 8
timeFrame: Week 8
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Change From Baseline to Week 8 in Fatigue Severity Scale
timeFrame: Baseline, Week 8
measure: Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint
timeFrame: Up to 8 weeks
measure: Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)
timeFrame: Baseline through Week 8
measure: Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score
timeFrame: Baseline, Week 8
measure: Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint
timeFrame: Baseline, up to week 8
measure: Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
measure: Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint
timeFrame: Baseline, up to Week 8
Other outcomes:
Locations:
city: Orlando
country: United States
facility: 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.
state: Florida
city: Prairie Village
country: United States
facility: 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.
state: Kansas
city: Allentown
country: United States
facility: 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.
state: Pennsylvania
city: Media
country: United States
facility: 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.
state: Pennsylvania
city: Bucharest
country: Romania
facility: 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.
city: Cluj-Napoca
country: Romania
facility: 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.
city: Lasi
country: Romania
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: