Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245583
Status:
TERMINATED
Last Update Posted:
2019-07-02
First Post:
2005-10-26
Brief Title:
Topiramate in the Treatment of Pathological Gambling
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Topiramate in the Treatment of Pathological Gambling A Randomized Double-Blind Placebo-Controlled Flexible-Dose Study
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the efficacy of topiramate in the treatment of pathological gambling Pathological gambling PG is a debilitating disorder generally leading to severe personal familial financial social and occupational impairments In PG the patient experiences a progressive inability to resist impulses to gamble and gambling significantly disrupt the patients functioning in the personal familial andor vocational spheres Topiramate has shown preliminary evidence of efficacy in some impulse control disorders
Detailed Description:
This is a 14-week outpatient multicenter randomized double-blind placebo-controlled flexible-dose study of topiramate in subjects with pathological gambling After giving informed consent subjects who meet all the inclusion and exclusion criteria may be enrolled The study will consist of three phases
WashoutScreening Phase up to 28 days prior to randomization or longer for those medications requiring a longer washout period
Double-Blind Phase Titration up to 6 weeks Maintenance 8 weeks and
Taper Phase approximately 1 week
The study medication will be titrated to 300 mgday or the subjects maximum tolerated dose MTD Subjects must reach a minimum dose of 50 mgday by Week 2 The taper phase will last approximately one week where subjects gradually reduce their medication until they are no longer taking study medication
Patient may also give an optional blood sample for pharmacogenomic testing
WashoutScreening Phase up to 28 days prior to randomization or longer for those medications requiring a longer washout period
Double-Blind Phase Titration up to 6 weeks Maintenance 8 weeks and
Taper Phase approximately 1 week
The study medication will be titrated to 300 mgday or the subjects maximum tolerated dose MTD Subjects must reach a minimum dose of 50 mgday by Week 2 The taper phase will last approximately one week where subjects gradually reduce their medication until they are no longer taking study medication
Patient may also give an optional blood sample for pharmacogenomic testing
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 |
|---|---|---|---|
| GCO 04-0023PS | None | None | None |