Phase 3
Completed N=608
A Safety Study in Participants With Major Depressive Disorder
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT01155661 ↗
Enrolled (actual)
608
Serious AEs
1.2%
Results posted
Apr 2018
Primary outcomePrimary: The Number of Participants Experiencing Clinically Significant Effects — 13 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 This can indicate results are unpublished — a known publication-bias signal.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 (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Clinically Significant Effects |
13 | — |
| SECONDARY Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) |
11.71; 0.17 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale |
-2.28 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) |
-8.64 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items |
-2.17; -2.38; -1.56; -1.97; -1.08; -1.88 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score |
-6.32 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S) |
-2.17 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores |
-1.25; -1.37; -1.30 | — |
| SECONDARY Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint |
0.772 | — |
| SECONDARY Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint |
0.758 | — |
| SECONDARY Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8 |
59.2 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score |
-4.57 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores |
-10.71; -3.36; -3.74; -3.61 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D) |
23.607 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) |
21.56 | — |
| SECONDARY Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint |
62.27; 30.18; 44.15; 4.75 | — |
| SECONDARY Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs) |
20.97 | — |
| SECONDARY Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8 |
47.7 | — |
| SECONDARY Plasma Concentration of LY2216684 |
29.6; 53.6 | — |
| SECONDARY The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint |
17; 408 | — |
| SECONDARY Change From Baseline to 54 Week Endpoint in Blood Pressure |
2.28; 2.17 | — |
| SECONDARY Change From Baseline to Week 54 Endpoint in Pulse Rate |
7.01 | — |
Eligibility Criteria
Inclusion Criteria
- Adults competent and able to give informed consent
- Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
- Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose
- Drug and dosage should be within the labeling guidelines for the specific country
- Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria
- Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI
- Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
- Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)
- Meet all other inclusion criteria per protocol
Exclusion Criteria
- Presence of another primary psychiatric illnesses:
- Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression within 1 year of screening
- Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
- Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
- Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
- Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
- Unstable medical conditions that contraindicate the use of LY2216684
- Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, urinary hesitation or retention
- Use of excluded concomitant or psychotropic medication other than SSRI
- Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
- History of treatment resistant depression as shown by:
- Have had 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, transcranial magnetic stimulation, or psychosurgery within the last year
- Meet any other exclusion criteria per protocol
Data sourced from ClinicalTrials.gov (NCT01155661). 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.