Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231101
Status:
UNKNOWN
Last Update Posted:
2006-10-17
First Post:
2005-09-30
Brief Title:
Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia
Sponsor:
Arthur P Noyes Research Foundation
Organization:
Arthur P Noyes Research Foundation
Study Overview
Official Title:
Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
A single-blind switching study in which forty subjects currently being treated with risperidone will be randomly assigned to either stay on risperidone or switched to quetiapine Various behavioral and biological measures will be used to compare smoking behavior over time in these two groups
Detailed Description:
STUDY SYNOPSIS
Study Design
Number of subjects enrolled Forty patients Two groups - 20 each
Number of centers One
Study design Single-blind Switching Paradigm
Extension None specifically although patients who do have a good clinical response to the treatment will probably be maintained on their medication at the discretion of their treating psychiatrist through normal hospital channels and therefore if desired it would be possible to formally re-evaluate their condition at some later time
Duration of study
Total duration of subject participation 14 weeks Duration of each study phase Screening 1-7 days Lead-in treatment with risperidone 2 weeks Switching phase 50 of the patients will be switched over a two-week period to quetiapine Active two group treatment 12 weeks
Visit interval or frequency variable depending on measurement Weekly - dispensing drug treatment team meeting Bi-weekly - labs certain side effect ratings Monthly - efficacy measures and side effect ratings Baseline Week 6 Week 12 - cognitive measures
Recruitmentenrollment duration Approximately 18 months
Subject Population
Specific subject populationdisease statedisorder being studied
Patients with DSM-IV schizophrenia all sub-types including schizoaffective disorder who are active heavy smokers at least one pack of cigarettes per day will be recruited To be included each patient will need to have received an adequate dose and duration of risperidone treatment monotherapy of at least 6 mg total daily for three months or more and who had a less-than-optimal response treatment Specifically a less-than-optimal response to risperidone is defined as a Total PANSS Score of 60 or more Additionally we will not enroll clinically stable patients who are satisfied with their ongoing treatment or patients judged to be treatment refractory using Kanes criteria
Subject setting both Norristown State Hospital inpatients and those enrolled in a partial hospital program will be recruited
Partial On the grounds of Norristown State Hospital are three partial hospital programs administered by the Montgomery County Office of Mental Health These are highly structured programs that will allow us to recruit subjects who are outpatients but living in well-supervised programs
Inpatient Norristown State Hospital 1001 Sterigere Street Norristown PA 19401
Study drug and dosing
Flexible To be enrolled all patients will have had an adequate treatment of risperidone defined as monotherapy of at least 6 mg total daily for three months or more prior to enrollment For those switched from risperidone to quetiapine it is expected this cross-titration will take two weeks longer titration may be used if necessary due to higher levels of risperidone By the end of the first week the risperidone will be reduced by 50 of the patients original dosage with the target dose of quetiapine being 400 mg total daily dose at the end of the first week By the end of the second week of titration the risperidone will be discontinued and the treating psychiatrist will continue to increase the quetiapine to the target of 600 mg total daily dose based on hisher clinical judgement then to reach 800 mg total daily dose by the end of the fourth week A lower dose will be possible due to emergent side effects but any patient not able to tolerate at least 400 mgday of quetiapine will be dropped from the study Quetiapine will be dosed BID
Comparators and dosing
Flexible As stated above all patients will have had an adequate treatment of risperidone prior to enrollment It is expected that the majority of those patients remaining on risperidone will continue to be treated at the 6 mgday dose although their treating psychiatrist will be able to suggest a lower dose due to side effects or increase the dose as necessary for greater efficacy Any patient requiring less that 4 mgday or more than 10 mgday will be dropped from the study While risperidone is usually dosed on a once per day basis throughout the switching phase of the study it will be dosed BID The possibility exists that oncedaily versus twicedaily dosing could be a factor that influences medication compliance rates between the groups and a source of bias Twicedaily dosing for both groups would also help to insure the blinding of the raters
It is important to note that no formal consensus exists regarding the milligram-to-milligram equivalency of risperidone and quetiapine However based on personal communication with Herbert Meltzer MD it seems that these dose ranges are thought to be comparable 1 mg risperidone approximately 100 mg quetiapine Thus the ideal comparison of 6 mgday risperidone to 600 mgday quetiapine should avoid criticism although the final group mean doses will finally be determined on the basis of individual patient treatment response and emergent side effects
Other treatments or programs
There will be no other study related treatment programs although each patient whether inpatient or partial hospital patient will continue to receive their usual hospital or clinic care on a regular basis It is critical to note however that any patient receiving ancillary behavioural psycho-educational or pharmacologic treatment for smoking cessation will not be enrolled due the inherent bias andor uncontrolled variance introduced by additional treatments
Study Design
Number of subjects enrolled Forty patients Two groups - 20 each
Number of centers One
Study design Single-blind Switching Paradigm
Extension None specifically although patients who do have a good clinical response to the treatment will probably be maintained on their medication at the discretion of their treating psychiatrist through normal hospital channels and therefore if desired it would be possible to formally re-evaluate their condition at some later time
Duration of study
Total duration of subject participation 14 weeks Duration of each study phase Screening 1-7 days Lead-in treatment with risperidone 2 weeks Switching phase 50 of the patients will be switched over a two-week period to quetiapine Active two group treatment 12 weeks
Visit interval or frequency variable depending on measurement Weekly - dispensing drug treatment team meeting Bi-weekly - labs certain side effect ratings Monthly - efficacy measures and side effect ratings Baseline Week 6 Week 12 - cognitive measures
Recruitmentenrollment duration Approximately 18 months
Subject Population
Specific subject populationdisease statedisorder being studied
Patients with DSM-IV schizophrenia all sub-types including schizoaffective disorder who are active heavy smokers at least one pack of cigarettes per day will be recruited To be included each patient will need to have received an adequate dose and duration of risperidone treatment monotherapy of at least 6 mg total daily for three months or more and who had a less-than-optimal response treatment Specifically a less-than-optimal response to risperidone is defined as a Total PANSS Score of 60 or more Additionally we will not enroll clinically stable patients who are satisfied with their ongoing treatment or patients judged to be treatment refractory using Kanes criteria
Subject setting both Norristown State Hospital inpatients and those enrolled in a partial hospital program will be recruited
Partial On the grounds of Norristown State Hospital are three partial hospital programs administered by the Montgomery County Office of Mental Health These are highly structured programs that will allow us to recruit subjects who are outpatients but living in well-supervised programs
Inpatient Norristown State Hospital 1001 Sterigere Street Norristown PA 19401
Study drug and dosing
Flexible To be enrolled all patients will have had an adequate treatment of risperidone defined as monotherapy of at least 6 mg total daily for three months or more prior to enrollment For those switched from risperidone to quetiapine it is expected this cross-titration will take two weeks longer titration may be used if necessary due to higher levels of risperidone By the end of the first week the risperidone will be reduced by 50 of the patients original dosage with the target dose of quetiapine being 400 mg total daily dose at the end of the first week By the end of the second week of titration the risperidone will be discontinued and the treating psychiatrist will continue to increase the quetiapine to the target of 600 mg total daily dose based on hisher clinical judgement then to reach 800 mg total daily dose by the end of the fourth week A lower dose will be possible due to emergent side effects but any patient not able to tolerate at least 400 mgday of quetiapine will be dropped from the study Quetiapine will be dosed BID
Comparators and dosing
Flexible As stated above all patients will have had an adequate treatment of risperidone prior to enrollment It is expected that the majority of those patients remaining on risperidone will continue to be treated at the 6 mgday dose although their treating psychiatrist will be able to suggest a lower dose due to side effects or increase the dose as necessary for greater efficacy Any patient requiring less that 4 mgday or more than 10 mgday will be dropped from the study While risperidone is usually dosed on a once per day basis throughout the switching phase of the study it will be dosed BID The possibility exists that oncedaily versus twicedaily dosing could be a factor that influences medication compliance rates between the groups and a source of bias Twicedaily dosing for both groups would also help to insure the blinding of the raters
It is important to note that no formal consensus exists regarding the milligram-to-milligram equivalency of risperidone and quetiapine However based on personal communication with Herbert Meltzer MD it seems that these dose ranges are thought to be comparable 1 mg risperidone approximately 100 mg quetiapine Thus the ideal comparison of 6 mgday risperidone to 600 mgday quetiapine should avoid criticism although the final group mean doses will finally be determined on the basis of individual patient treatment response and emergent side effects
Other treatments or programs
There will be no other study related treatment programs although each patient whether inpatient or partial hospital patient will continue to receive their usual hospital or clinic care on a regular basis It is critical to note however that any patient receiving ancillary behavioural psycho-educational or pharmacologic treatment for smoking cessation will not be enrolled due the inherent bias andor uncontrolled variance introduced by additional treatments
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