A Study of Flexible Dose LY2216684 as Adjunctive Treatment for Patients With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

Phase 1

• Conditions: Major depressive disorder (MDD); MedDRA version: 14.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-021216-41-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

[1] meet criteria for primary MDD, as defined by DSM-IV-TR criteria, as
determined by clinical assessment and confirmed by the MINI at Visit 1
[2] are adult male or female outpatients at least 18 years of age or older at the
time of informed consent, who provide informed consent by signing the
appropriate ICFs. Patients must be competent and able to give their own
informed consent.
[3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) may participate in the study. Women must test negative for pregnancy at the time of study entry based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of investigational product. Men participating agree to use a reliable
method of birth control during the study, and for 1 month following the last dose of the investigational product.
[4] are being treated with one of the following SSRIs that have been approved for
MDD treatment within the participating country: escitalopram, citalopram,
sertraline, fluoxetine, paroxetine, or fluvoxamine; and have been treated with
their SSRI at least 6 weeks prior to Visit 2 with at least the last 4 consecutive
weeks at a stable optimized dose prior to Visit 2. The SSRI should be
prescribed, including dose, in a manner consistent with labeling
guidelines within the participating country.
[5] meet criteria for partial response at Visit 1 and Visit 2, as defined by
investigator’s opinion that the patient has experienced a minimally clinically
meaningful improvement with the SSRI treatment.
[6] have a GRID-HAMD17 total score?16 at Visit 1.
[7] have ?75% improvement on the current SSRI at Visit 1, determined by the
MGH-ATRQ-Modified Version
[8] have an education level and a degree of understanding such that the patient
can communicate with the site study personnel
[9] are judged to be reliable and agree to keep all appointments for clinic visits,
tests, and procedures, including venipuncture, and examinations required by
the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[10] are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
[11] are Lilly employees
[12] are currently enrolled in, or discontinued within the last 30 days from, a
clinical study involving an investigational drug or device or off-label use of a
drug or device (other than the investigational product used in this study), or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study
[13] have previously completed or withdrawn from this study or any other study
investigating LY2216684
[14] have had or currently have any additional ongoing DSM-IV-TR Axis I
condition other than MDD that was considered the primary diagnosis within
1 year of Visit 1
[15] have had any anxiety disorder that was considered a primary diagnosis within
the past year (including panic disorder, obsessive-compulsive disorder [OCD],
posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD],
and social phobia, but excluding specific phobias)
[16] have a current or previous diagnosis of bipolar disorder, schizophrenia, or
other psychotic disorder
[17] have a history of substance abuse within the past 1 year (drug categories
defined by DSM-IV-TR), and/or substance dependence within the past 1 year,
not including caffeine and nicotine
[18] have an Axis II disorder that, in the judgment of the investigator, would
interfere with compliance with the study protocol
[19] patient meets criteria for treatment-resistant depression, defined as a lack of clinically meaningful 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[20] have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
[21] have received electroconvulsive therapy (ECT) in the past year
[22] are women who are pregnant or breast-feeding
[23] are judged, in the opinion of the investigator, to be at serious risk for harm to
self or others
[24] have a serious or unstable medical illness, including cardiovascular, hepatic,
respiratory, hematologic, endocrinologic, neurologic disease, renal disease, or
clinically significant laboratory or ECG abnormality. Clinically significant
lab or ECG abnormalities are those which, in the judgment of the investigator,
indicate a serious medical problem or require significant intervention.
[25] have any diagnosed medical condition which could be exacerbated by
noradrenergic agents, including unstable hypertension or unstable heart
disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or history of
urinary hesitancy or retention
[26] have a history of severe allergies to more than 1 class of medication or
multiple adverse drug reactions
[27] have a history of any seizure disorder (other than febrile seizures)
[28] have received treatment with a monoamine oxidase inhibitor (MAOI) within
14 days prior to Visit 1 or have a potential need to use an MAOI within 3 days
after discontinuation from the study
[29] require psychotropic medication other than sedative/hypnotic medication, as specified in the protocol
[30] are taking or have received treatment with a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified