Schizophrenia
Conditions
Brief summary
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.
Detailed description
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.
Interventions
None listed
Sponsors
US Department of Veterans Affairs
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia * age 18-60 yrs
Exclusion criteria
* claustrophobia * weight \> 250 lbs * metal in body other than dental fillings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuronal Response During Sensory Gating | Immediate | Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risperidone Patients with schizophrenia treated with risperidone | 20 |
| Clozapine Patients with schizophrenia treated with clozapine | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Risperidone | Clozapine | Total |
|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 10.9 | 34.0 years STANDARD_DEVIATION 8.5 | 34.9 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Neuronal Response During Sensory Gating
Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risperidone | Neuronal Response During Sensory Gating | .12 % BOLD signal | Standard Deviation 0.1 |
| Clozapine | Neuronal Response During Sensory Gating | .11 % BOLD signal | Standard Deviation 0.1 |