Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273702
Status:
COMPLETED
Last Update Posted:
2007-04-30
First Post:
2006-01-06
Brief Title:
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Status:
COMPLETED
Status Verified Date:
2007-04
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:
After completing all screening evaluations subjects will receive unblinded N-Acetyl Cysteine 600 mgday for 2 weeks The dose will be raised to 1200 mgday at visit 4 and to 1800 mgday at visit 6 unless clinical improvement has been attained at a lower dose clinical improvement will be assessed by the investigator with respect to gambling thoughts urges and behavior If it is clinically necessary to modify this schedule eg because of side effects or an adequate response to a lower dose the dose will be raised more slowly or the target dose will not be reached
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry Psychotherapy of any form including cognitive-behavioral therapy will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry
Subjects will be evaluated with the PG-YBOCS G-SAS CGI HAM-D HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study Medication side effects will be evaluated at each study visit A tablet count will be kept for each dose of medication taken
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry Psychotherapy of any form including cognitive-behavioral therapy will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry
Subjects will be evaluated with the PG-YBOCS G-SAS CGI HAM-D HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study Medication side effects will be evaluated at each study visit A tablet count will be kept for each dose of medication taken
Detailed Description:
Before beginning N-Acetyl Cysteine all subjects will receive a psychiatric medical and family history evaluation as well as the Structured Clinical Interview for DSM-IV SCID-P for Axis I disorders At the screening visit patients will also receive standard laboratory tests including ß-HCG and a physical examination
The following instruments will be completed at the screening visit and periodically throughout the study 1 Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling PG-YBOCS a reliable and valid semi-structured clinician-administered scale that assesses current severity of PG 2 Gambling Symptom Assessment Scale G-SAS a reliable and valid self-report measure of gambling symptoms 3 the 17-item Hamilton Rating Scale for Depression HAM-D 4 the 17-item Hamilton Rating Scale for Anxiety HAM-A 5 Clinical Global Impression scale 6 the Sheehan Disability Inventory and 7 the Quality of Life Inventory Safety evaluations including pulse and blood pressure and assessment of side effects will be done at each visit
After completing all screening evaluations subjects will receive unblinded N-Acetyl Cysteine 600 mgday for 2 weeks The dose will be raised to 1200 mgday at visit 4 and to 1800 mgday at visit 6 unless clinical improvement has been attained at a lower dose clinical improvement will be assessed by the investigator with respect to gambling thoughts urges and behavior If it is clinically necessary to modify this schedule eg because of side effects or an adequate response to a lower dose the dose will be raised more slowly or the target dose will not be reached
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry Psychotherapy of any form including cognitive-behavioral therapy will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry
Subjects will be evaluated with the PG-YBOCS G-SAS CGI HAM-D HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study Medication side effects will be evaluated at each study visit A tablet count will be kept for each dose of medication taken
The following instruments will be completed at the screening visit and periodically throughout the study 1 Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling PG-YBOCS a reliable and valid semi-structured clinician-administered scale that assesses current severity of PG 2 Gambling Symptom Assessment Scale G-SAS a reliable and valid self-report measure of gambling symptoms 3 the 17-item Hamilton Rating Scale for Depression HAM-D 4 the 17-item Hamilton Rating Scale for Anxiety HAM-A 5 Clinical Global Impression scale 6 the Sheehan Disability Inventory and 7 the Quality of Life Inventory Safety evaluations including pulse and blood pressure and assessment of side effects will be done at each visit
After completing all screening evaluations subjects will receive unblinded N-Acetyl Cysteine 600 mgday for 2 weeks The dose will be raised to 1200 mgday at visit 4 and to 1800 mgday at visit 6 unless clinical improvement has been attained at a lower dose clinical improvement will be assessed by the investigator with respect to gambling thoughts urges and behavior If it is clinically necessary to modify this schedule eg because of side effects or an adequate response to a lower dose the dose will be raised more slowly or the target dose will not be reached
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry Psychotherapy of any form including cognitive-behavioral therapy will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry
Subjects will be evaluated with the PG-YBOCS G-SAS CGI HAM-D HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study Medication side effects will be evaluated at each study visit A tablet count will be kept for each dose of medication taken
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