Trial Outcomes & Findings for fMRI Cholinergic Mechanisms in Schizophrenia (NCT NCT01191827)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

Immediate

Results posted on

2015-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Risperidone Patients with schizophrenia treated with risperidone	Clozapine Patients with schizophrenia treated with clozapine
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

fMRI Cholinergic Mechanisms in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperidone n=20 Participants Patients with schizophrenia treated with risperidone	Clozapine n=20 Participants Patients with schizophrenia treated with clozapine	Total n=40 Participants Total of all reporting groups
Age, Continuous	35.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	34.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	34.9 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Risperidone n=20 Participants Patients with schizophrenia treated with risperidone	Clozapine n=20 Participants Patients with schizophrenia treated with clozapine
Neuronal Response During Sensory Gating	.12 % BOLD signal Standard Deviation .1	.11 % BOLD signal Standard Deviation .1

Adverse Events

Risperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clozapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Biologist

Denver VA Medical Center

Phone: 303-724-6232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place