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Health Condition(s) or Problem
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Major Depressive Disorder
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Lay Summary
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The primary objective of this study is to assess whether LY2216684 12 mg to 18 mg flexible
dose once daily is superior to placebo Once Daily in the adjunctive treatment of patients
with major depressive disorder (MDD) who are partial responders to their Selective Serotonin
Reuptake Inhibitor Treatment (SSRI).
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- 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
- Are being treated with one of the following SSRIs: escitalopram, citalopram,
sertraline, fluoxetine, paroxetine, or 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 MDD, as defined by Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) criteria
- Meet criteria for partial response, as defined by investigator's opinion that patient
has experienced a minimal clinically meaningful improvement with SSRI
- Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score
greater than or equal to 16 at screening
- Have less than or equal to 75% improvement on the current SSRI at screening
determined by the Massachusetts General Hospital Antidepressant Treatment Response
Questionnaire (MGH-ATRQ)
Exclusion Criteria:
- Have had or currently have any additional ongoing DSM-IV-TR Axis 1 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 [OCD], posttraumatic
stress disorder [PTSD], generalized anxiety disorder [GAD], 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 an 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, history of urinary hesitancy 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 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 patient has treatment-resistant depression
- Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic
stimulation (TMS), or psychosurgery
- Have received electroconvulsive therapy (ECT) in the past year
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Who cannot enter the trial
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Inclusion Criteria:
- 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
- Are being treated with one of the following SSRIs: escitalopram, citalopram,
sertraline, fluoxetine, paroxetine, or 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 MDD, as defined by Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) criteria
- Meet criteria for partial response, as defined by investigator's opinion that patient
has experienced a minimal clinically meaningful improvement with SSRI
- Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score
greater than or equal to 16 at screening
- Have less than or equal to 75% improvement on the current SSRI at screening
determined by the Massachusetts General Hospital Antidepressant Treatment Response
Questionnaire (MGH-ATRQ)
Exclusion Criteria:
- Have had or currently have any additional ongoing DSM-IV-TR Axis 1 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 [OCD], posttraumatic
stress disorder [PTSD], generalized anxiety disorder [GAD], 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 an 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, history of urinary hesitancy 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 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 patient has treatment-resistant depression
- Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic
stimulation (TMS), or psychosurgery
- Have received electroconvulsive therapy (ECT) in the past year
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What will happen
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Drug; LY2216684; 12 mg to 18 mg Administered orally, once daily for 11 weeks; LY2216684; Drug; Placebo; Administered orally, once daily for 11 weeks; Placebo
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Primary aim
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Change From Baseline to week 11 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
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Secondary Aim
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Change from baseline to week 11 in Sheehan Disability Scale (SDS) Global Functional Impairment scale; Baseline, 11 weeks; No; Change from baseline to week 11 in Fatigue Associated with Depression (FAsD) impact subscale score; Baseline, 11 weeks; No; Percentage of patients achieving a MADRS total score of less than or equal to 10 at week 11; 11 weeks; No; Percentage of patients achieving a MADRS total score of less than or equal 10 at least 2 consecutive measurements including the patient's last measurement; through 11 weeks; No; Change from baseline to week 11 in Hospital and Anxiety and Depression Scale (HADS) anxiety subscale score; Baseline, 11 weeks; No; Percentage of patients who have a greater than or equal to 50 percent improvement in the MADRS total score from baseline to week 11; Baseline, 11 weeks; No; Change from baseline to week 11 in HADS depression subscale score; Baseline, 11 weeks; No; Change from baseline to week 11 in MADRS individual items; Baseline, 11 weeks; No; Change from baseline to week 11 in Clinical Global Impressions of Severity (CGI-S); Baseline, 11 weeks; No; Change from baseline to week 11 in FAsD average score and experience subscale score; Baseline, 11 weeks; No; Change from baseline to week 11 in Sheehan Disability Scale (SDS) items; Baseline, 11 weeks; No; Change from baseline to week 11 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF); Baseline, 11 weeks; No; Change from baseline to week 11 in the EuroQol Questionnaire-5 Dimension (EQ-5D); Baseline, 11 weeks; No; Percentage of treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale (C-SSRS); Through 12 weeks; Yes; Change from baseline to week 11 in Arizona Sexual Experiences (ASEX) scale; Baseline, 11 weeks; Yes; Change from baseline to week 11 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ); Baseline, 11 weeks; Yes; Change from baseline to week 11 in blood pressure; Baseline, 11 weeks; Yes; Change from baseline to week 11 in pulse rate; Baseline, 11 weeks; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England, Scotland
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Location
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Bexhill-on-sea, Glasgow, Chesterfield
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