Recruiting

Quetiapine

Sponsor:

Arthur P. Noyes Research Foundation

Code:

NCT00231101

Conditions

Smoking Behavior in Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Quetiapine

Study Details

Brief summary:

A single-blind switching study in which forty subjects currently being treated with risperidone will be randomly assigned to either stay on risperidone or switched to quetiapine. Various behavioral and biological measures will be used to compare smoking behavior over time in these two groups.

Conditions

Smoking Behavior in Schizophrenia

Study ID

NCT00231101

Start date

Jan, 2004

Status verified date

Sep, 2005

Completion date

Jun, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients (male or female) between 18-65 years of age must be diagnosed as having DSM-IV schizophrenia (any subtype including schizoaffective disorder).
2. Patients must have shown a less-than-optimal clinical response to an adequate course of risperidone treatment and must be willing to agree to the possibility of receiving quetiapine as an alternative treatment for their mild to moderate psychotic symptoms. We define an adequate course of treatment as three or more months of at least 6 mg/day of risperidone. We define less-than-adequate treatment as a Total PANSS Score of 60 or more.
3. Patients must be active cigarette smokers. We define active cigarette smoking as patients who consume one pack of cigarettes or more per day. Although there is no standard for defining active cigarette smokers, it has been our experience that the high rate of smoking activity on the hospital wards can have the effect of small elevations in cotinine levels even among "non-smoking" patients through second hand smoke. Therefore, we want to insure that we enroll "heavy" smokers.
4. Patients must be able to fully participate in the informed consent and HIPAA process, or have a legal guardian able to participate

Exclusion Criteria:

1. Patients who have had an adequate clinical response to risperidone and are considered by themselves or their treating psychiatrist to be clinically stable.
2. Patients who are judged to be treatment refractory, which we define as documented treatment failure with 3 FDA-approved antipsychotic medications administered for an adequate duration in a sufficient dosage (6 or more weeks of 1000 mg/day chlorpromazine equivalents).
3. Patients at the time of screening who have clinically significant akathisia (Barnes global score >2), Parkinsonian symptoms symptoms (Simpson Angus total score >3), or significant EPS (indicated by treatment with benztropine, lorazepam or propranolol).
4. ECG abnormalities consistent with significant or acute cardiac disease.
5. History of significant or unstable hypertension during the screening examination outside the range from 90/60 to 140/90, or a pulse outside of the range of 60 to 100 beats per minute.
6. Any history of seizures or primary CNS disease (other than tardive dyskinesia or extrapyramidal symptoms from psychotropic medications), comatose states, bone marrow depression, significant cardiovascular, renal or hepatic disease, brain trauma, chronic obstructive lung disease and/or pulmonary emphysema, or a mental deficiency.
7. Active drug or alcohol addiction within the past 3-month period.
8. Symptoms of significant physical illness in the 4-week period prior to enrollment, excluding mild upper respiratory or gastrointestinal disorders.
9. Clinical laboratory findings that indicate the presence of a pathological condition in the judgment of the principal investigator.
10. Having received any investigational drug in the 4 weeks preceding the study.
11. Pregnant or lactating patients are excluded. Pregnancy must be excluded by laboratory tests prior to beginning the study. Female patients judged to have potential for pregnancy (sexually-active females who do not use an approved form of contraception) will be excluded.
12. At serious suicidal risk.

Study Design

Enrollment

40 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Educational/Counseling/Training

Interventions and Outcome Measures

Interventions

Quetiapine

Primary outcome measure

  • The Fagerstrom Test for Nicotine Dependence,weekly measures of expired CO and blood levels of cotinine. The endpoints for assessing nicotine receptor activation will include: the auditory P50, visuospatial working memory, and the CPT. [ Time Frame: undefined ]
  • Changes in psychopathology will be performed monthly PANSS, CGI, and the SANS. [ Time Frame: undefined ]
  • EPS will be measured weekly using the NRS, and the Barnes Akathisia Scale. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Richard C Josiassen, Ph.D.

richardjosiassen@noyesfoundation.net

Locations

Arthur P. Noyes Research Foundation

Recruiting

Norristown, Pennsylvania, United States, 19401

Contacts

Richard C Josiassen, Ph.D.

richardjosiassen@noyesfoundation.net

Principal Investigator:

Richard C Josiassen, Ph.D.

More Information

Sponsor

Arthur P. Noyes Research Foundation

Last update posted

Oct 17, 2006

Last verified

Sep, 2005

Keywords

  • Smoking
  • Schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arthur P. Noyes Research Foundation on 2006-10-17.