Trial · NCT00245583

Topiramate in the Treatment of Pathological Gambling

NCT00245583, Phase 3, Terminated, Icahn School of Medicine at Mount Sinai; results first posted 2019-07-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topiramate in the Treatment of Pathological Gambling. Trials, record NCT00245583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00245583

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topiramate in the Treatment of Pathological Gambling
NCT number: NCT00245583
Status: Terminated
Phases: Phase 3
Enrollment: 42 participants, actual
Lead sponsor: Icahn School of Medicine at Mount Sinai
Conditions: Pathological Gambling
Interventions: Topiramate, Placebo
First posted: 2005-10-28
Last updated: 2019-07-02
Results first posted: 2019-07-02
Limitations and caveats: Small sample size and short study duration. Selection bias - sample unrepresentative of PG in the community due to exclusion criteria.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Baseline	The obsessions subscale of the Yale-Brown Obsessive Compulsive Scale modified for PG (PG-YBOCS) measures the severity and change in severity of PG symptoms such as thoughts/urges and behaviors and has been shown to be reliable and valid and correlate with global severity and South Oaks Gambling Screen scores. The scale is a clinician-rated, each item rated from 0 (no symptoms) to 4 (extreme symptoms), Each component, Obsession and Compulsion, score ranges from 0-20, yielding a total possible score range from 0 to 40, with higher score indicating more symptoms.
Primary	Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	14 weeks	The obsessions subscale of the Yale-Brown Obsessive Compulsive Scale modified for PG (PG-YBOCS) measures the severity and change in severity of PG symptoms such as thoughts/urges and behaviors and has been shown to be reliable and valid and correlate with global severity and South Oaks Gambling Screen scores. The scale is a clinician-rated, each item rated from 0 (no symptoms) to 4 (extreme symptoms), Each component, Obsession and Compulsion, score ranges from 0-20, yielding a total possible score range from 0 to 40, with higher score indicating more symptoms.
Secondary	Gambling-Symptom Assessment Scale Total Score	baseline and 14 weeks	The Gambling-Symptom Assessment Scale (G-SAS) is a 12-item self-rated measure that is designed to assess gambling symptom severity and change during treatment. Each item is scored on a 4 point scale from 0-4 with 0 meaning no symptoms and 4 meaning extreme symptoms. The total score is 0 - 48, with higher score indicating more gambling problem. Scores 7 and lower are considered normal behavior, 8-20 are considered a mild gambling problem, 21-30 are considered a moderate gambling problem, 31-40 are considered a severe gambling problem and 40-48 are considered an extreme gambling problem.
Secondary	Barratt Impulsiveness Scale-11	baseline	The Barratt Impulsiveness Scale (BIS-11) is a questionnaire designed to assess the personality/behavioral construct of impulsiveness, composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Subscale attentional score 8-32, subscale motor score 11-44, subscale nonplanning score 11-44, with higher scores for each subscale indicating worse outcomes. Total score from 30-120, with higher score indicating more impulsive symptoms. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4 Total scores of 72+ = high impulsiveness Total scores between 52 and 71 = within normal limits for impulsiveness Total scores lower than 52 are representative of an individual that is either extremely over-controlled or who has not honestly completed the questionnaire
Secondary	Barratt Impulsiveness Scale-11	week 14	The Barratt Impulsiveness Scale (BIS-11) is a questionnaire designed to assess the personality/behavioral construct of impulsiveness, composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Subscale attentional score 8-32, subscale motor score 11-44, subscale nonplanning score 11-44, with higher scores for each subscale indicating worse outcomes. Total score from 30-120, with higher score indicating more impulsive symptoms. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4 Total scores of 72+ = high impulsiveness Total scores between 52 and 71 = within normal limits for impulsiveness Total scores lower than 52 are representative of an individual that is either extremely over-controlled or who has not honestly completed the questionnaire
Secondary	Young Mania Rating Scale (YMRS)	baseline and week 14	The YMRS is an 11-item scale used to assess the severity of mania and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. YMRS total score varies between zero and 60, with higher score indicating more symptoms. A score of \<= 12 indicates remission of symptoms.
Secondary	Montgomery-Asberg Depression Rating Scale	baseline and week 14	The Montgomery-Åsberg Depression Rating Scale (MADRS) is a psychological questionnaire used by clinicians to assess the severity of depression among patients who have a diagnosis of depression. The MADRS depression test includes 10 items and uses a 0 to 6 severity scale. Total score from 0-60. Higher scores indicate increasing depressive symptoms.
Secondary	The Hamilton Anxiety Rating Scale	baseline and week 14	Hamilton Anxiety Rating Scale (HARS) - It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Higher score indicates more symptoms.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Baseline		score on a scale	MEAN
PRIMARY	Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	14 weeks		score on a scale	MEAN
SECONDARY	Gambling-Symptom Assessment Scale Total Score	baseline and 14 weeks	those who returned for week 14 visit included in data results	score on a scale	MEAN
SECONDARY	Barratt Impulsiveness Scale-11	baseline		score on a scale	MEAN
SECONDARY	Barratt Impulsiveness Scale-11	week 14		score on a scale	MEAN
SECONDARY	Young Mania Rating Scale (YMRS)	baseline and week 14	those who returned for week 14 visit included in data results	score on a scale	MEAN
SECONDARY	Montgomery-Asberg Depression Rating Scale	baseline and week 14	those who returned for week 14 visit included in data results	score on a scale	MEAN
SECONDARY	The Hamilton Anxiety Rating Scale	baseline and week 14	those who returned for week 14 visit included in data results	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Topiramate	Obsessions	12.65	Standard Deviation 2.08	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Placebo	Obsessions	12.95	Standard Deviation 2.24	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Topiramate	Compulsions	11.10	Standard Deviation 23.75	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Placebo	Compulsions	12.27	Standard Deviation 2.91	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Topiramate	Total	23.75	Standard Deviation 4.80	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Placebo	Total	25.23	Standard Deviation 4.89	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Topiramate	Obsessions	6.17	Standard Deviation 3.28	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Placebo	Obsessions	7.62	Standard Deviation 3.66	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Topiramate	Compulsions	5.28	Standard Deviation 4.71	score on a scale
Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)	Placebo	Compulsions	6.92	Standard Deviation 4.48	score on a scale

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	20
Overall Study	STARTED	Placebo	22
Overall Study	COMPLETED	Topiramate	14
Overall Study	COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Topiramate	6
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tiredness	General disorders	Topiramate	1	20
other	Tiredness	General disorders	Placebo	2	22
other	Headache	General disorders	Topiramate	2	20
other	Headache	General disorders	Placebo	3	22
other	Nausea	Gastrointestinal disorders	Topiramate	3	20
other	Nausea	Gastrointestinal disorders	Placebo	4	22
other	Shoulder Pain	Musculoskeletal and connective tissue disorders	Topiramate	1	20
other	Shoulder Pain	Musculoskeletal and connective tissue disorders	Placebo	2	22

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate	0	20
Total, all-cause mortality	Placebo	0	22
Total, other adverse events	Topiramate	7	20
Total, other adverse events	Placebo	11	22
Total, serious adverse events	Topiramate	0	20
Total, serious adverse events	Placebo	0	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21486110	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Topiramate vs Placebo: deaths from any cause	Trial comparisons
Topiramate vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00245583

GET https://conductscience.org/api/trials/v1/NCT00245583/results?page=2

API reference For AI assistants