Phase 3
Completed N=288
A Study of LY2216684 in Participants With Major Depression Disorder
Source: ClinicalTrials.gov NCT01370499 ↗Enrolled (actual)
288
Serious AEs
0.5%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Clinically Significant Events — 0; 1; 0; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Events |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Percentage of Participants With Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
8.72; 8.70; 0.51; 0.00 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items |
-4.33; -6.63; -0.36; -1.01; -0.51; -0.92 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Clinical Global Impression - Severity (CGI-S) |
-0.80; -0.78 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores |
-0.32; -0.18; -0.28; -0.15; -0.34; -0.19 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores |
-1.46; -0.55; -1.95; -1.24 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores |
-3.11; -2.37; -0.98; -1.42; -1.01; -0.66 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D) |
9.445; 9.989 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) |
6.28; 5.19 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) |
-4.02; -2.53 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Arizona Sexual Experiences (ASEX) Scale |
-0.65; -0.40 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Blood Pressure |
6.66; 3.68; 7.55; 6.34 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Pulse Rate |
17.00; 10.98 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01370499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.