Schizophrenia Clinical Trial
Official title:
Risperidone Effects On Frontal And Temporal Cortical Function In Schizophrenia Patients Undergoing FMRI Cognitive Task Performance
The general aim is to compare the effects of typical and atypical antipsychotic medication on brain structure and function. A parallel group treatment trial will be utilized to compare the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its amelioration by atypical antipsychotic drugs.
The general aim of this study was to determine the neuroanatomic basis for cognitive
pathology in schizophrenia, as well as the effects of treatment with typical and atypical
antipsychotics on clinical symptoms, neurocognition and brain function, as measured with
function magnetic resonance imaging. Subjects underwent a randomized parallel group
treatment trial that consisted of: a four-week Thiothixene treatment period, followed by
randomization, two-weeks cross titration, and six-weeks of double blind treatment with
Risperidone (RIS) or Olanzapine (OLZ). Twenty-three patients with schizophrenia or
schizoaffective disorder and fifteen healthy control subjects were initially enrolled.
Diagnosis was established with the SCID. Subjects were assessed at two time points, at
baseline after four weeks of Thiothixene treatment and at follow up, after eight weeks of
double-blind atypical antipsychotic treatment. Controls were assessed once. Symptom severity
was assessed using the PANSS. Cognitive functions associated with frontal and temporal
cortical regions were probed with a neurocognitive testing battery using standardized
attention, executive function and working memory tasks. Frontal and temporal cortical
function was assessed with fMRI during the performance of visual and auditory oddball tasks.
The visual task oddball task consisted of identifying an infrequent square presented within
a series of frequent squares. The auditory oddball task consisted of identifying an
infrequent pitch-deviant target tone embedded within a series of frequent standard tones.
Thirteen patients and eleven controls completed fMRI at baseline and follow-up.
The results indicated that patients treated with the typical neuroleptic Thiothixene showed
significantly smaller extents of activations in superior temporal, anterior cingulate and
thalamic regions as compared to control subjects during the auditory oddball task. Although
treatment with atypical neuroleptics considerably reduced group differences in cortical
activation between controls and patients, the current sample size proved to be insufficient
to yield statistically significant group by time interactions. The percent signal change
data was in the same direction, but proved to be less sensitive to group differences than
the extent of activation. The group differences were not pronounced during the visual
oddball task, but were in the same direction.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |