Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01282632
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2011-01-21
Brief Title:
Risperidone vs Olanzapine as add-on Treatment in Treatment Resistant Depression
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Double Blind Pilot Trial to Evaluate Efficacy Trends and Safety of Risperidone and Olanzapine as add-on Therapy to Serotonin Type Antidepressants in Subjects With Treatment Resistant Depression TRD
Status:
COMPLETED
Status Verified Date:
2010-09
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:
Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar depression Some data support the use of both Risperidone and Olanzapine but there are no direct comparisons of their relative efficacy and tolerability in treatment resistant depression The current study was designed as a pilot study to examine efficacy and tolerability of Olanzapine vs Risperidone add on to a failed serotonin re-uptake inhibitor SSRI in depression
Detailed Description:
Overview of Study Design
This is a Canadian multicentre double blind comparator trial in 42 patients with TRD TRD is defined as the failure to respond adequately to two successive courses of different antidepressants at an adequate dose at least fluoxetine 20 mg citalopram 20 mg paroxetine 20 mg sertraline 100 mg fluvoxamine 150 mg venlafaxine 225 mg for at least 4 weeks All subjects at entry to the study will be currently not responding to treatment of at least 4 weeks duration of a serotonin re-uptake inhibitor SSRI or a selective nor-epinephrine and serotonin re-uptake inhibitor SNRI Non-response is defined as a score of 3 minimal improvement or worse on the Clinical global Impression of Improvement
The objective is to assess the appropriateness of the trial design and to determine sample size requirements for future controlled trials In addition the efficacy and safety of oral doses of risperidone 5-3 mgday and olanzapine 25-15 mgday as add-on therapy to any SSRI or SNRI in treatment resistant depression will be evaluated Subjects meeting the screening criteria will enter a 6-week trial with risperidone or olanzapine added on to the current SSRI or SNRI therapy
A medical psychiatric history HAM-D-29 only the first 17 items will be used for outcome MADRS and HAM-A will be obtained at screening At subsequent visits HAM-D HAM-A and MADRS will be performed and adverse events spontaneous and using the CASES checklist and concomitant medications will be collected
Recruitment
Subjects will drawn from two sources
1 Outpatients currently attending the clinic at the sites These subjects will already be in treatment or may have been referred from the local communities of the clinics involved in this study for consultation Should these subjects drop out or once they have completed the study they will receive the treatment as usual at each site
2 Advertisements Advertisements will be placed in local media radio television newspaper identifying the nature of the study and providing a contact number These advertisements will be approved by the local IRBs prior to posting
This is a Canadian multicentre double blind comparator trial in 42 patients with TRD TRD is defined as the failure to respond adequately to two successive courses of different antidepressants at an adequate dose at least fluoxetine 20 mg citalopram 20 mg paroxetine 20 mg sertraline 100 mg fluvoxamine 150 mg venlafaxine 225 mg for at least 4 weeks All subjects at entry to the study will be currently not responding to treatment of at least 4 weeks duration of a serotonin re-uptake inhibitor SSRI or a selective nor-epinephrine and serotonin re-uptake inhibitor SNRI Non-response is defined as a score of 3 minimal improvement or worse on the Clinical global Impression of Improvement
The objective is to assess the appropriateness of the trial design and to determine sample size requirements for future controlled trials In addition the efficacy and safety of oral doses of risperidone 5-3 mgday and olanzapine 25-15 mgday as add-on therapy to any SSRI or SNRI in treatment resistant depression will be evaluated Subjects meeting the screening criteria will enter a 6-week trial with risperidone or olanzapine added on to the current SSRI or SNRI therapy
A medical psychiatric history HAM-D-29 only the first 17 items will be used for outcome MADRS and HAM-A will be obtained at screening At subsequent visits HAM-D HAM-A and MADRS will be performed and adverse events spontaneous and using the CASES checklist and concomitant medications will be collected
Recruitment
Subjects will drawn from two sources
1 Outpatients currently attending the clinic at the sites These subjects will already be in treatment or may have been referred from the local communities of the clinics involved in this study for consultation Should these subjects drop out or once they have completed the study they will receive the treatment as usual at each site
2 Advertisements Advertisements will be placed in local media radio television newspaper identifying the nature of the study and providing a contact number These advertisements will be approved by the local IRBs prior to posting
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