Clinical trial NCT01173601: A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Official title: A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Fixed-Dose 12 Milligrams (mg) and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 1416
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 purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.

Detailed description: Following the Confirmation Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they met the following randomization criteria: had \<25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14. Participants who did not meet criteria received adjunctive placebo to preserve the blind.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder (MDD)
* 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
* Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country. 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

Exclusion Criteria:

* Presence of another primary psychiatric illness:

  * 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 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 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 that could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle 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 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 participant has treatment-resistant depression
* Have a lifetime history of vagal nerve stimulation, transcranial magnetic stimulation, or psychosurgery
* Have received electroconvulsive therapy in the last year
* Enrollment in a clinical study for an investigational drug
* Serious or unstable medical condition
* History of seizure disorders
* Have initiated psychotherapy or other non-drug therapies (such as acupuncture or hypnosis) within 12 weeks prior to enrollment or any time during the study. Have no change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at 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

Primary outcomes:
measure: Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Randomization, 8 weeks
Secondary outcomes:
measure: Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Scale
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score
timeFrame: Randomization, 8 weeks
measure: Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 up to Week 8
timeFrame: Randomization up to 8 weeks
measure: Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
timeFrame: Randomization up to 8 weeks
measure: Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
timeFrame: Randomization, 8 weeks
measure: Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8
timeFrame: Randomization up to 8 weeks
measure: Change From Randomization to Week 8 in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)
timeFrame: Randomization, 8 weeks
measure: Percentage of Treatment Emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Randomization through 8 weeks
measure: Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
timeFrame: Randomization, 8 weeks
measure: The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype
timeFrame: Through 8 weeks
measure: Change From Randomization to Week 8 in Blood Pressure (BP)
timeFrame: Randomization, 8 weeks
measure: Change From Randomization to Week 8 in Pulse Rate
timeFrame: Randomization, 8 weeks
measure: Pharmacokinetics: Plasma Concentrations of LY2216684
timeFrame: 1 week, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Irvine
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: California
city: La Habra
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: California
city: Redlands
country: United States
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state: California
city: Denver
country: United States
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state: Colorado
city: Jacksonville
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Baltimore
country: United States
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state: Maryland
city: Saint Louis
country: United States
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state: Missouri
city: Berlin
country: United States
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state: New Jersey
city: Jamaica
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Dayton
country: United States
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state: Ohio
city: Middleburg Heights
country: United States
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state: Ohio
city: Allentown
country: United States
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state: Pennsylvania
city: Memphis
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Murray
country: United States
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state: Utah
city: Milwaukee
country: United States
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state: Wisconsin
city: Fukuoka
country: Japan
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city: Fukushima
country: Japan
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city: Hyogo
country: Japan
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city: Kanagawa
country: Japan
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city: Nagano
country: Japan
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city: Saga
country: Japan
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city: Tokyo
country: Japan
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city: Daugavpils
country: Latvia
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city: Jelgava
country: Latvia
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city: Liepaja
country: Latvia
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city: Sigulda
country: Latvia
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city: Strenci
country: Latvia
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city: ?Uromin
country: Poland
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city: Bialystok
country: Poland
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city: Bydgoszcz
country: Poland
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city: Chelmno
country: Poland
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city: Gdansk
country: Poland
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city: Gorlice
country: Poland
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city: Katowice
country: Poland
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city: Leszno
country: Poland
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city: Lublin
country: Poland
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city: Tuszyn
country: Poland
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city: Ekaterinburg
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Rostov-On-Don
country: Russian Federation
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city: Bellville
country: South Africa
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city: Cape Town
country: South Africa
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city: Centurion
country: South Africa
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city: George
country: South Africa
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city: West Cape
country: South Africa
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city: Chernihiv District
country: Ukraine
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city: Dnipropetrovsk
country: Ukraine
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city: Donetsk
country: Ukraine
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city: Kherson
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Lugansk
country: Ukraine
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city: Odesa
country: Ukraine
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city: Poltava
country: Ukraine
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city: Simferopol
country: Ukraine
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city: Uzhorod
country: Ukraine
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city: Vinnytsya
country: Ukraine
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: Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
citation: Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.