A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00840034
First received: February 9, 2009
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for patients with major depressive disorder (MDD), who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) (as defined by history).


Condition Intervention Phase
Depressive Disorder, Major
Drug: LY2216684
Drug: Placebo
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 Augmentation With LY2216684 for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) total score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) individual items [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-Severity) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Fatigue Associated with Depression Patient-Reported Outcome (FAsD PRO) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale for Fatigue (VAS-F) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale for Pain (VAS-P) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Survey- Short Form (Q-LES-Q-SF) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Colombia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 227
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684 Drug: LY2216684
Starting dose is 6 mg, then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered PO QD for up to 12 weeks
Placebo Comparator: Placebo Drug: Placebo
3 tablets PO QD for up to 12 weeks

Detailed Description:

This is a 12 week multi-center, double-blind, placebo-controlled study on the efficacy of LY2216684 augmentation of selective serotonin reuptake inhibitors (SSRIs) in patients with MDD who have a partial response to treatment with an SSRI. While remaining on a steady dose of their SSRI treatment at entry into the study, patients will be randomly assigned to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute treatment.

  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 MDD as defined by DSM-IV-TR criteria
  • Meet criteria for partial response to an adequate course of treatment defined by the investigator's opinion that patient had attained at least minimal improvement on their current SSRI treatment
  • Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
  • Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal 16 to at both study entry and study enrollment
  • SSRI treatment for at least 6 weeks at a stable dose for at least 2 weeks prior to study enrollment
  • Stated patient preference for augmentation rather than switching antidepressant treatment

Exclusion Criteria:

  • Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
  • Have previously completed or withdrawn from this study or any other study investigating LY2216684
  • Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
  • Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of study entry
  • Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia or other psychotic disorder
  • Have a history of substance abuse within the past 1 year
  • Have an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the protocol
  • Have had a 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 patient has treatment-resistant depression
  • Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year
  • Women who are pregnant or breastfeeding
  • Patients who are judged to be at serious risk for harm to self or others
  • Have a serious or unstable medical illness
  • Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
  • Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
  • Have a history of any seizure disorder (other than febrile seizures)
  • Are taking noradrenergic psychotropic medications, such as tricyclic antidepressants or serotonin norepinephrine reuptake inhibitors (SNRI)
  • Have received treatment with a MAOI within 14 days prior to study entry
  • Require psychotropic medication other than sedative/hypnotic medication for sleep
  • Are taking or have received treatment with any excluded medication within 7 days prior to study enrollment
  • Have a thyroid stimulating hormone (TSH ) level outside the established reference range
  • Have initiate or discontinued hormone therapy within the previous 3 months prior to enrollment
  • Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
  • A positive urine drug screen for any substance of abuse at study entry
  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: NCT00840034

  Show 24 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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00840034     History of Changes
Other Study ID Numbers: 12850, H9P-MC-LNDK
Study First Received: February 9, 2009
Last Updated: October 25, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014