Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464698
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2007-04-23
Brief Title:
Duloxetine for the Treatment of Obsessive Compulsive Disorder OCD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Duloxetine for the Treatment of Obsessive Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2019-03
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:
FIJ-MC-1003
Brief Summary:
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder
Detailed Description:
Obsessive compulsive disorder affects approximately 3 of the population Treatment options include the selective serotonin reuptake inhibitors SSRIs dual serotonin and norepinephrine reuptake inhibitors SNRIs and behavioral therapy Duloxetine is a new SNRI This study aims to assess the efficacy of duloxetine for the treatment of OCD
Before subjects give written informed consent they are made aware of alternatives to participation in this study which can include independently seeking pharmacotherapy or cognitive behavioral treatment for OCD Patients will then begin open-label treatment with duloxetine at 30 mgday and will be seen again in one week Visit 2 At Visit 2 patients will be assessed and if they are not experiencing any significant side effects the dose will be increased to 60 mgday Patients who are experiencing significant side effects at 30 mgday will be discontinued from the study and offered standard treatment in our clinic Patients taking 60 mgday will then return for assessment in four weeks Visit 3 At this time if they are not experiencing any significant side effects the dose will then be increased to 120 mgday Patients who are unable to tolerate 120 mgday will have their dose decreased back down to 60 mgday and will continue the trial End of study final statistical analyses will be conducted both including and excluding these patients Remaining assessments will be every 4 weeks Visits 4 5 6 Thus in total this is a 17-week study with 12 weeks at the high dose believed to be necessary for response
At each visit following the initial visit patients will be assessed using the Y-BOCS BDI BAI and CGI The Q-LES-Q will only be administered at the initial and last visit
The study procedure is similar to standard medical treatment for OCD at MGH Like standard care participants start on the lowest dose of the medication and then increase that dose to the maximally tolerated level Barring any significant side effects the patient remains on that dose for 4-8 weeks to provide the medication with an adequate trial period At the end of that period efficacy would be assessed and other alternatives would be discussed
One difference between the study and standard care is that the study will provide more assessment through verbal and written scales This additional assessment could greatly benefit the patient as they decide between other treatment options Another difference is that participants cannot be involved in current behavior therapy throughout the study Many patients choose to pursue medical treatment without behavior therapy in standard care however in standard care they have the option of pursuing both concurrently or pursuing just behavior therapy If a patient wishes to pursue just behavior therapy or receive medication and therapy concurrently then other forms of treatment at MGH might be more appropriate If they only want medical treatment the study is similar to standard care at a lower cost
Before subjects give written informed consent they are made aware of alternatives to participation in this study which can include independently seeking pharmacotherapy or cognitive behavioral treatment for OCD Patients will then begin open-label treatment with duloxetine at 30 mgday and will be seen again in one week Visit 2 At Visit 2 patients will be assessed and if they are not experiencing any significant side effects the dose will be increased to 60 mgday Patients who are experiencing significant side effects at 30 mgday will be discontinued from the study and offered standard treatment in our clinic Patients taking 60 mgday will then return for assessment in four weeks Visit 3 At this time if they are not experiencing any significant side effects the dose will then be increased to 120 mgday Patients who are unable to tolerate 120 mgday will have their dose decreased back down to 60 mgday and will continue the trial End of study final statistical analyses will be conducted both including and excluding these patients Remaining assessments will be every 4 weeks Visits 4 5 6 Thus in total this is a 17-week study with 12 weeks at the high dose believed to be necessary for response
At each visit following the initial visit patients will be assessed using the Y-BOCS BDI BAI and CGI The Q-LES-Q will only be administered at the initial and last visit
The study procedure is similar to standard medical treatment for OCD at MGH Like standard care participants start on the lowest dose of the medication and then increase that dose to the maximally tolerated level Barring any significant side effects the patient remains on that dose for 4-8 weeks to provide the medication with an adequate trial period At the end of that period efficacy would be assessed and other alternatives would be discussed
One difference between the study and standard care is that the study will provide more assessment through verbal and written scales This additional assessment could greatly benefit the patient as they decide between other treatment options Another difference is that participants cannot be involved in current behavior therapy throughout the study Many patients choose to pursue medical treatment without behavior therapy in standard care however in standard care they have the option of pursuing both concurrently or pursuing just behavior therapy If a patient wishes to pursue just behavior therapy or receive medication and therapy concurrently then other forms of treatment at MGH might be more appropriate If they only want medical treatment the study is similar to standard care at a lower cost
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FIJ-MC-1003 | None | None | None |