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

NCT ID: NCT00840034

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-01-31

Brief Summary

The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for 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) (as defined by history).

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 participants 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, participants will be randomly assigned to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute treatment.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LY2216684

Group Type: EXPERIMENTAL

LY2216684

Intervention Type: DRUG

Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 tablets PO QD for up to 12 weeks

Interventions

LY2216684

Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.

Intervention Type: DRUG

Placebo

3 tablets PO QD for up to 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR criteria)
• Meet criteria for partial response to an adequate course of treatment defined by the investigator's opinion that participant had attained at least minimal improvement on their current Selective serotonin reuptake inhibitor (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 participant 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 participant 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
• Participants 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 monoamine oxidase inhibitor (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

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.

Birmingham, Alabama, United States

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.

Little Rock, Arkansas, United States

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Carson, California, United States

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Costa Mesa, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Coral Springs, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Smyrna, Georgia, United States

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Oak Brook, Illinois, United States

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Lafayette, Indiana, United States

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Baltimore, Maryland, United States

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Saint Charles, Missouri, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Fresh Meadows, New York, United States

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Rochester, New York, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27685842 (View on PubMed)

Other Identifiers

H9P-MC-LNDK

Identifier Type: OTHER

Identifier Source: secondary_id

12850

Identifier Type: -

Identifier Source: org_study_id