Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02153502
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2014-05-29
Brief Title:
Efficacy Safety and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of AVP-786 Deuterium Modified Dextromethorphan HydrobromideQuinidine Sulfate as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this 10-week study are to evaluate the efficacy safety and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder MDD who have shown an inadequate response to standard antidepressant treatment A secondary objective of this study is to assess the pharmacokinetics PK of AVP-786 and potential correlations with pharmacodynamic effects
Detailed Description:
It is estimated that up to approximately 200 patients will participate in the study at approximately 30 enrolling centers in the US
Eligible patients for this study must have MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR criteria and have shown an inadequate response to standard antidepressant treatment
This is a multicenter randomized double-blind placebo-controlled study of 10 weeks duration
Following screening procedures for assessment of inclusion and exclusion criteria eligible patients will be randomized into the study Study medication will be administered orally twice a day BID 1 capsule in the morning and 1 capsule in the evening approximately 12 hours apart throughout the treatment period
Eligible patients for this study must have MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR criteria and have shown an inadequate response to standard antidepressant treatment
This is a multicenter randomized double-blind placebo-controlled study of 10 weeks duration
Following screening procedures for assessment of inclusion and exclusion criteria eligible patients will be randomized into the study Study medication will be administered orally twice a day BID 1 capsule in the morning and 1 capsule in the evening approximately 12 hours apart throughout the treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None