Clinical trial NCT01299272: A Study in Prevention of Re-emergence of Depression Symptoms
Official title: LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 1249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period.

This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

Detailed description: In order to enter the Stabilization Open-label Period, participants must have met remission criteria, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤10 at Week 8. In order to enter the Double-blind Randomization Withdrawal Period, participants must have met randomization criteria, defined as a MADRS total score ≤10 at Weeks 18, 19, and 20.

Eligibility criteria: Inclusion Criteria:

* Outpatients with clinical diagnosis of Major Depressive Disorder (MDD)
* Using a reliable method of birth control
* Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
* Have a partial response to SSRI treatment
* Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
* Reliable and able to keep all scheduled appointments
* Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years

Exclusion Criteria:

* Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening
* Have a current or any 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 a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention
* Have initiated or discontinued hormone therapy (including birth control or thyroid hormone) within the previous 3 months prior to enrollment
* Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery
* Have received electroconvulsive therapy (ECT) in the past year
* Have a serious or unstable medical condition
* Have a history of seizure disorders
* Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
* Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
* Are pregnant or breastfeeding
* Meet criteria for treatment-resistant depression

Primary outcomes:
measure: Percentage of Participants Who Meet Criteria for Re-emergence of Depressive Symptoms Estimated by Kaplan-Meier Product Limit Method (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization up to 44 weeks
Secondary outcomes:
measure: Percentage of Participants With Re-emergence of Depressive Symptoms (Double-blind Randomized Withdrawal Period)
timeFrame: Week 44
measure: Change From Randomization in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the Clinical Global Impression of Severity (CGI-S) Scores at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the Sheehan Disability Scale (SDS) Items at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, up to Week 44
measure: Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization through Week 44
measure: Change From Randomization in the Arizona Sexual Experiences (ASEX) Questionnaire at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Randomization in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 8 (Acute Open-label Period)
timeFrame: Baseline, up to Week 8
measure: Change From Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 20 (Stabilization Open-label Period)
timeFrame: Week 8, up to Week 20
measure: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 8 (Acute Open-label Period)
timeFrame: Baseline, up to Week 8
measure: Change From Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 20 (Stabilization Open-label Period)
timeFrame: Week 8, up to Week 20
measure: Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 8 (Acute Open-label Period)
timeFrame: Baseline, up to Week 8
measure: Change From Week 8 in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 20 (Stabilization Open-label Period)
timeFrame: Week 8, up to Week 20
measure: Change From Baseline in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 8 (Acute Open-label Period)
timeFrame: Baseline, up to Week 8
measure: Change From Week 8 in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 20 (Stabilization Open-label Period)
timeFrame: Week 8, up to Week 20
measure: Change From Baseline in the Sheehan Disability Scale (SDS) Items up to Week 8 (Acute Open-label Period)
timeFrame: Baseline, up to Week 8
measure: Change From Week 8 in the Sheehan Disability Scale (SDS) Items up to Week 20 (Stabilization Open-label Period)
timeFrame: Week 8, up to Week 20
measure: Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 20 (Open-label Period)
timeFrame: Baseline, up to Week 20
measure: Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Open-label Period)
timeFrame: Baseline through Week 20
measure: Change From Baseline in the Arizona Sexual Experiences (ASEX) Questionnaire up to Week 20 (Open-label Period)
timeFrame: Baseline, up to Week 20
measure: Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 20 (Open-label Period)
timeFrame: Baseline, up to Week 20
measure: Change From Randomization in Blood Pressure at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Baseline in Blood Pressure up to Week 20 (Open-label Period)
timeFrame: Baseline, up to Week 20
measure: Change From Randomization in Pulse Rate at Week 44 (Double-blind Randomized Withdrawal Period)
timeFrame: Randomization, Week 44
measure: Change From Baseline in Pulse Rate up to Week 20 (Open-label Period)
timeFrame: Baseline, up to Week 20
Other outcomes:
Locations:
city: Redlands
country: United States
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state: California
city: Sherman Oaks
country: United States
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state: California
city: Wildomar
country: United States
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state: California
city: Coral Gables
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Libertyville
country: United States
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state: Illinois
city: Lafayette
country: United States
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state: Indiana
city: Terre Haute
country: United States
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state: Indiana
city: Prairie Village
country: United States
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state: Kansas
city: Boston
country: United States
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state: Massachusetts
city: Las Vegas
country: United States
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state: Nevada
city: Cherry Hill
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Brooklyn
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Philadelphia
country: United States
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state: Pennsylvania
city: Austin
country: United States
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state: Texas
city: Clinton
country: United States
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state: Utah
city: Spokane
country: United States
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state: Washington
city: Middleton
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Córdoba
country: Argentina
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city: La Plata
country: Argentina
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city: Heusden-Zolder
country: Belgium
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city: Split
country: Croatia
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city: Zagreb
country: Croatia
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city: Arcachon
country: France
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city: Caen
country: France
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city: Dole
country: France
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city: Douai
country: France
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city: Elancourt
country: France
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city: Fains
country: France
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city: Toulon
country: France
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city: Toulouse
country: France
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city: Dresden
country: Germany
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city: Hamburg
country: Germany
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city: Hannover
country: Germany
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city: Oranienburg
country: Germany
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city: Haidari
country: Greece
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city: Thessaloniki
country: Greece
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city: Tripoli
country: Greece
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city: Camaiore-Viareggio
country: Italy
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city: Catania
country: Italy
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city: Colleferro
country: Italy
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city: Ferrara
country: Italy
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city: Siena
country: Italy
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city: Gwangju
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Fracc. Bosques Del Prado Norte
country: Mexico
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city: Guadalajara
country: Mexico
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city: Ponce
country: Puerto Rico
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city: San Juan
country: Puerto Rico
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city: Bucharest
country: Romania
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city: Focsani
country: Romania
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city: Targu Mures
country: Romania
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city: Moscow
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Smolensk
country: Russian Federation
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city: Stavropol
country: Russian Federation
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city: Tomsk
country: Russian Federation
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city: Banska Bystrica
country: Slovakia
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city: Bratislava
country: Slovakia
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: Svidnik
country: Slovakia
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: Zvolen
country: Slovakia
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: Madrid
country: Spain
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: Palma De Mallorca
country: Spain
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: Salamanca
country: Spain
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: Sevilla
country: Spain
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: Adapazari
country: Turkey
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: Diyarbakir
country: Turkey
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:
citation: Oakes TM, Dellva MA, Waterman K, Greenbaum M, Poppe C, Goldberger C, Ahl J, Perahia DG. Edivoxetine compared to placebo as adjunctive therapy to selective serotonin reuptake inhibitors in the prevention of symptom re-emergence in major depressive disorder. Curr Med Res Opin. 2015 Jun;31(6):1179-89. doi: 10.1185/03007995.2015.1037732. Epub 2015 May 6.