A Study in Prevention of Re-emergence of Depression Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01299272
First received: February 16, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The primary purpose of this study is to assess whether LY2216684 (12 mg to 18 mg once daily) is superior to placebo as adjunctive therapy to selective serotonin reuptake inhibitor (SSRI) in patients with major depressive disorder (MDD) who were initially partial responders to a SSRI in the prevention of re-emergence of depression symptoms in patients with MDD who met remission criterion during open label treatment and randomization criteria during a stabilization period. This trial consists of two distinct periods; an open label treatment period, which consists of two parts, 8 weeks open label with movement to 10-12 weeks open label stabilization IF patients are in remission at end of 8 weeks (open label for 18 to 20 weeks total) followed by a randomized blinded period for 24 to 26 weeks.


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2216684
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to re-emergence of depressive symptoms [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with re-emergence of depressive symptoms [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual item scores (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscale scores (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression of Severity (CGI-S) scores (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the Fatigue Associated with Depression (FAsD) average score, experience subscale score, and impact subscale score (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the Sheehan Disability Scale (SDS) items (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Change in the EuroQol Questionnaire-5 Dimension (EQ-5D) index scores, visual analog scale (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: No ]
  • Number of participants with treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(double-blind randomized withdrawal period) [ Time Frame: Randomization up 44 weeks ] [ Designated as safety issue: Yes ]
  • Change in the Arizona Sexual Experiences (ASEX) Questionnaire (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: Yes ]
  • Change in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) scores (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: Yes ]
  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual item scores (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Change in the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscale scores (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression of Severity (CGI-S) scores (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Change in the Fatigue Associated with Depression (FAsD) average score, experience subscale score, and impact subscale score (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Change in the Sheehan Disability Scale (SDS) items (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Change in the EuroQol Questionnaire-5 Dimension (EQ-5D) index scores, visual analog scale (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: No ]
  • Number of participants with treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: Yes ]
  • Change in the Arizona Sexual Experiences (ASEX) Questionnaire (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: Yes ]
  • Change in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) scores (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: Yes ]
  • Change in blood pressure (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: Yes ]
  • Change in blood pressure (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: Yes ]
  • Change in pulse rate (double-blind randomized withdrawal period) [ Time Frame: Randomization up to 44 weeks ] [ Designated as safety issue: Yes ]
  • Change in pulse rate (open-label period) [ Time Frame: Baseline to randomization (up to 18 - 20 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2045
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684
12 - 18 mg orally, once daily for 8 weeks, in addition to the participant continuing their stable optimized dose of SSRI. At 8 weeks participants meeting remission criteria are eligible to continue same dose of LY2216684 and SSRI orally, daily for up to 12 weeks. Participants meeting criteria for randomization will continue at current LY2216684 and SSRI dose orally, daily for up to an additional 26 weeks.
Drug: LY2216684
Administered orally
Placebo Comparator: Placebo
12 - 18 mg LY2216684 orally, once daily for 8 weeks, in addition to the participant continuing their stable optimized dose of SSRI. At 8 weeks participants meeting remission criteria are eligible to continue LY2216684 and SSRI orally, daily for up to 12 weeks. Participants meeting randomization criteria will be switched from LY2216684 to Placebo and current SSRI dose orally, daily, for up to an additional 26 weeks.
Drug: LY2216684
Administered orally
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with clinical diagnosis of Major Depressive Disorder (MDD)
  • Using a reliable method of birth control
  • Are taking an SSRI approved for MDD treatment within the patient'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 an 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, history of urinary hesitation or retention
  • Have initiated or discontinued hormone therapy (including, birth control, 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
  • Serious or unstable medical condition
  • 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
  • Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
  • Are pregnant or breastfeeding
  • Meets criteria for treatment-resistant depression
  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: NCT01299272

  Show 77 Study Locations
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01299272     History of Changes
Other Study ID Numbers: 11317, H9P-MC-LNBN
Study First Received: February 16, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Croatia: Ministry of Health and Social Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: National Institute of Health
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Korea: Ministry for Health, Welfare and Family Affairs
Mexico: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014