Topiramate in the Treatment of Pathological Gambling

NCT00245583 | Terminated Phase 3 Results

• 2 other identifiers: CAPSS-314GCO 04-0023PS*
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has shown preliminary evidence of efficacy in some impulse control disorders.

Conditions

Pathological Gambling

Keywords

Pathological Gambling; Compulsive Gambling; Gambling; topiramate

Outcome Measures

Primary Outcomes (2)

• Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)

  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.

  Baseline

• Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)

  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.

  14 weeks

Secondary Outcomes (6)

• Gambling-Symptom Assessment Scale Total Score

  baseline and 14 weeks

• Barratt Impulsiveness Scale-11

  baseline

• Barratt Impulsiveness Scale-11

  week 14

• Young Mania Rating Scale (YMRS)

  baseline and week 14

• Montgomery-Asberg Depression Rating Scale

  baseline and week 14

Study Arms (2)

Topiramate

EXPERIMENTAL

25mg to 300mg daily dose

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

placebo equivalent tablets

Drug: Placebo

Interventions

Topiramate DRUG

minimum does of 50mg/day

Also known as: Topamax

Topiramate

Placebo DRUG

matching tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a current DSMV-IV-TRTM diagnosis of pathological gambling supported by the Structured Clinical Interview for Pathological Gambling (SCI-PG).
• Subjects must have a severity score of ³ 4 (moderately ill) on the Clinical Global Impressions Scale - Severity (CGI-S) at Visit 1A (Day -28).
• Subjects must have a severity score of ³5 on the South Oaks Gambling Screen (SOGS) at Visit 1B (Day -7).
• Subjects must have a score of ³2 for item number 1 on the Gambling Symptom Assessment Scale (G-SAS) at Visit 1B (Day -7) and Visit 2 (Day 1).
• Subjects must have a minimum score of \>10 on the obsession subscale (questions 1-5) of the Pathological Gambling - Yale Brown Obsessive Compulsive Scale (PG-Y-BOC) at Visits 1B (Day -7) and 2 (Day 1).
• Subjects must score ≤15 on the Young Mania Rating Scale (YMRS) at Visits 1B (Day -7) and 2 (Day 1).
• Subjects must be between 18 and 70 years of age, inclusive.
• Subjects must provide contact information for themselves to be used by the site in case of a missed appointment.
• Subjects may be male or female and must be in generally good health as confirmed by medical history and physical examination, laboratory tests and vital signs.
• Female subjects must be:
• postmenopausal for at least one year, or
• surgically sterile, or
• practicing an effective method of birth control (e.g., oral contraceptives, contraceptive injections, intrauterine device, spermicide with barrier, contraceptive patch, contraceptive vaginal ring, male partner sterilization, or abstinence and agree to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence) before entry and throughout the study; have a negative urine pregnancy test at Visits 1B (Day -7) and 2 (Day 1).
• Subjects must be able to take oral medication, adhere to the medication regimens and be willing to return for regular visits.
• Subjects must be able and willing to read written instructions and complete all scales and inventories required by the protocol.

You may not qualify if:

• Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-TRä supported by the SCID-I/P, other than pathological gambling, that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
• Subjects with a history of personality disorder (e.g., schizotypal or borderline) considered by the investigator to likely interfere with assessment or compliance with treatment.
• Subjects who have a current or recent (within 3 months of Visit 2, Day 1) DSM-IV-TRTM diagnosis of substance abuse or dependence, with the exception of nicotine and caffeine abuse or dependence.
• Subjects receiving formal psychotherapy for pathological gambling (with the exception of Gamblers Anonymous) within the 4 weeks prior to Visit 1B (Day -7).
• Note: Formal psychotherapy is defined as behavioral therapy, cognitive therapy, cognitive-behavioral therapy, psychoanalysis, etc. for the treatment of a clinical diagnosis or for which a healthcare professional is billing for such therapy.
• \- Subjects who have begun to receive formal psychotherapy for a psychiatric disorder, other than pathological gambling, within 3 months prior to Visit 1B (Day -7).
• Note: Subjects who have been engaged in formal psychotherapy for a condition other than pathological gambling for \>3 months and plan to maintain therapy throughout the study will be considered on a case-by-case basis.
• Subjects with a score of \>24 on the Montgomery-Asberg Depression Rating Scale (MADRS) at Visit 1B (Day -7) and Visit 2 (Day 1).
• Subjects who are expected to stay in a restricted environment.
• Subjects who have taken a prohibited medication described in the Concomitant Therapy section of the protocol and who have not met the washout criteria specified in Attachment 15.
• Subjects with a positive urine drug screening \[benzodiazepines, phencyclidine, cocaine, amphetamines, tetrahydrocannabinol (THC), and opiates\] at Visit 1B (Day -7).
• Subjects who are pregnant or lactating.
• Subjects who are members of the same household.
• Subjects with a history of nephrolithiasis.
• Subjects known to have clinically significant medical conditions, including but not limited to:

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Ortho-McNeil, Inc.: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• Berlin HA, Braun A, Simeon D, Koran LM, Potenza MN, McElroy SL, Fong T, Pallanti S, Hollander E. A double-blind, placebo-controlled trial of topiramate for pathological gambling. World J Biol Psychiatry. 2013 Mar;14(2):121-8. doi: 10.3109/15622975.2011.560964. Epub 2011 Apr 12.

  PMID: 21486110 RESULT

MeSH Terms

Conditions

Gambling

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

Small sample size and short study duration. Selection bias - sample unrepresentative of PG in the community due to exclusion criteria.

Results Point of Contact

• Title: Dr. Heather Berlin
• Organization: Icahn School of Medicine at Mount Sinai

heather.berlin@mssm.edu

212-241-4761

Study Officials

• Eric Hollander, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Study Start: October 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-07

Locations

US (1)