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Phase 3 Completed N=608 Treatment

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 This can indicate results are unpublished — a known publication-bias signal.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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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