Getting Help > Clinical Trials > Florida

A Randomized, Double-Blind, Placebo-Controlled Trial of Escitalopram in Pathological Gamblers
Gainesville, Jacksonville

Principal Investigator: Wayne K. Goodman

Description of Study: The purpose of this research is to assess the efficacy and tolerability of escitalopram in the treatment of pathological gambling disorder. The hypothesis is that escitalopram plus active participation in Gamblers Anonymous (GA) will be more effective than placebo plus Gamblers Anonymous for patients seeking treatment for pathological gambling.

This study will be a 12-week, double-blind, parallel group escitalopram and placebo in subjects meeting DSM-IV criteria for pathologic gambling disorder. All subjects will be required to attend gambler anonymous meetings on at least a weekly basis during the time of their participation in the study (standard treatment). Those who are randomized to receive escitalopram will be started at 10 mg/day and titrated upward until maximum symptom improvement or 30 mg/day is achieved. The clinician will monitor side effects at every visit and routine laboratory tests will be done at the screening and final visits.

Eligibility Criteria:
- Must provide written informed consent prior to study entry
- Male or female outpatients between 18 and 81 years
- Primary DSM-IV Axis I diagnosis of pathologic gambling disorder
- Willingness to attend Gamblers Anonymous meetings
- Hamilton Depression Rating Scale (HDRS 17-item) score < 25)
- Hamilton Anxiety Scale (HARS) score < 16
- South Oaks Gambling Screen (SOGS) scale score > 5
- No other principal Axis-I diagnosis currently present based on psychiatric evaluation and administration of the Structured Clinical Interview for DSM-IV (SCID) (co-morbid nicotine dependence, depression and specific phobia will not be excluded)
- Psychotropic drug-free period of 2 weeks or more (4 weeks or more for fluoxetine) prior to baseline study visit (as confirmed by negative urine drug screen).
- Normal or clinically unremarkable results on physical exam and laboratory tests, or abnormalities may be clinically insignificant as judged by and documented by the investigator.
- In female subjects of childbearing potential, negative urine pregnancy test (per dipstick determination) and agreement to use a reliable method of contraception during the entire study.

Exclusion Criteria:
- Patients with any current or past history of malignancy (other than basal cell carcinoma) history of clinically significant endocrine, gastrointestinal, hematological, neurological, hepatic, renal, or cardiac disease
- Currently receiving outpatient gambling treatment or individual or group therapy (except gambler's anonymous)
- Prior history of non-response to an adequate trial of escitalopram and/or known hypersensitivity to escitalopram, citalopram, or compound related to escitalopram or citalopram
- Patients who currently meet lifetime criteria for a DSM-IV diagnosis of Bipolar disorder; Schizophrenia or and psychotic disorder; Obsessive Compulsive Disorder; Panic Disorder.
- Patients who meet DSM-IV criteria for psychoactive substance use/abuse/dependence, and/or alcohol abuse/dependence within 3 months of screening visit
- Patients with severe personality disorder (e.g., antisocial or borderline personality disorder) that would be considered to adversely impact on their ability to comply with the requirements of the study protocol
- Women who are pregnant, intend to become pregnant during the time of the study, and/or those who are currently breastfeeding
- Patients who test positive for illicit drugs on the urine drug screen.

Contact: Nicola Ricciuti, RN, (352) 265-0162