BENITIONSClinical Trial Intelligence

Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis

Фаза 4 Завершено NCT04004416

ЗаболеваниеSchizophrenia, Bipolar Disorder, Healthy, Psychosis
ФазаФаза 4
СпонсорUniversity of Michigan
СтатусЗавершено
Участники143 участн.
ВмешательствоPlacebo and fMRI, Lorazepam and fMRI
Дата начала16.01.2020
Дата завершения28.02.2025
Публикация результатов17.06.2026

Кратко

The purpose of this study is to better understand mental illness and will test the hypotheses that, while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam. This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as psychosis which includes conditions like schizophrenia, schizoaffective disorder, and mood disorders like bipolar disorder). The study will also enroll eligible participants between the ages of 18 and 60 without any psychiatric illness to compare their brains. The study will require participants to have 3-4 sessions over a few weeks. The initial assessments (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the fMRI. During the fMRI, the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, vital signs will be taken, they will be asked to complete more qols, and women of ch

Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures

Approximately 28 days · AU

Early Psychosis Patients - Lorazepam 0.01 mg/kg-0.174 ± 0.183 AU
Early Psychosis Patients - Lorazepam 0.02 mg/kg-0.037 ± 0.138 AU
Early Psychosis Patients - Placebo-0.177 ± 0.209 AU
Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg-0.167 ± 0.12 AU
Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg-0.046 ± 0.169 AU
Schizophrenia or Schizoaffective Disorder Patients - Placebo-0.175 ± 0.207 AU
p-value0.938
F-Value (Estimation of Variance).136

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