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A Study of LY2216684 in Patients With Major Depression Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01370499
First received: June 8, 2011
Last updated: April 14, 2014
Last verified: January 2014

June 8, 2011
April 14, 2014
August 2011
January 2014   (final data collection date for primary outcome measure)
Number of participants with clinically significant events [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01370499 on ClinicalTrials.gov Archive Site
  • Number of participants with suicidal behaviors and ideations measured by the Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 52 week endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual items [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Fatigue Associated with Depression (FAs-D) average score and subscale scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscale scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Sheehan Disability Scale (SDS) total score and subscale scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 52 week endpoint in Arizona Sexual Experiences (ASEX) scale [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of LY2216684 in Patients With Major Depression Disorder
Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Adult Patients With Major Depressive Disorder Who Were Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

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 patients with Major Depressive Disorder (MDD) who were partial responders to their SSRI treatment.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: LY2216684
Administered orally
Experimental: LY2216684
12 mg to 18 mg Administered orally, once daily for 52 weeks
Intervention: Drug: LY2216684
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
January 2014
January 2014   (final data collection date for primary outcome measure)

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 patient 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 stud.
  • Participants have a positive urine drug screen (UDS) for any substances of abuse on entering trial
  • Participants have significantly violated rules that a patient must comply with during Study LNBM or Study LNBQ
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01370499
12849, H9P-JE-LNDJ
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP