A Study of LY2216684 in Participants With Major Depression Disorder

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin Reuptake Inhibitors (SSRI) for up to approximately 1 year in participants with Major Depressive Disorder (MDD) who were partial responders to their SSRI treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Phenylethyl Alcohol; Serotonin; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• Participants must have completed Study LNBM: NCT01173601 or Study LNBQ: NCT01187407

• Participants must be competent and able to give their own informed consent

Exclusion Criteria:

• Participants that have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorder, fourth edition, text revision (DSM-IV-TR) Axis I condition other than major depression that was considered the primary diagnosis within 1 year of entering trial

• Participants that have had any anxiety disorder that was considered a primary diagnosis within the past year

• Participants that have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder

• Participants that have a history of substance abuse within the past 1 year, and/or substance dependence within the past 1 year, not including caffeine and nicotine

• Participants that have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study

• Participants that have had a lack of full 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

• Participants that have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year

• Participants who are women who are pregnant or breastfeeding

• Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others

• Participants that have a serious or unstable medical illness

• Participants that have any diagnosed medical condition which could be exacerbated by noradrenergic agents

• Participants that have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions

• Participants that have a history of any seizure disorder (other than febrile seizures)

• Participants that have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to entering trial or have a potential need to use an MAOI within 3 days after discontinuation from the study

• Participants that require psychotropic medication other than sedative/hypnotic medication for sleep

• Participants who are taking or have received treatment with any excluded medications within 7 days prior to entering trial

• Participants that have a thyroid stimulating hormone (TSH) level outside the laboratory established reference range. Participants previously diagnosed with hyperthyroidism or hypothyroidism who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid will be allowed to participate in the study.

• Participants that have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment

• Participants that have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study.

• Participants have a positive urine drug screen (UDS) for any substances of abuse on entering trial

• Participants have significantly violated rules that a participant must comply with during Study LNBM: NCT01173601 or Study LNBQ: NCT01187407