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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2025
  • participants needed
    232
  • sponsor
    University of Michigan
Updated on 25 February 2021
remission
anxiety
benzodiazepines
psychosis
bipolar disorder
psychiatric disorder
antipsychotics
psychotropic drugs
suicide
suicidal
schizophrenia
lorazepam
functional magnetic resonance imaging
schizoaffective disorder
psychotic symptoms
schizophreniform disorder
substance use disorder
gamma-aminobutyric acid
gamma-aminobutyric acid (gaba)

Summary

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 schizophrenia, bipolar disorder, and schizoaffective disorder). The study will also enroll eligible participants without any psychiatric illness, to compare their brains.

The study will require participants to have 3-4 sessions over a few weeks. The first session (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.

Description

Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award number.

Details
Condition Psychosis, Bipolar Disorder, Schizophrenia, healthy, Schizophrenia and Schizoaffective Disorders, Bipolar Disorders (Pediatric), Schizophrenia and Schizoaffective Disorders (Pediatric), Manic Disorders, schizophreniform disorder, schizophrenia disorders, schizoaffective disorder, psychotic disorders, psychotic, psychotic disorder
Treatment Placebo and fMRI, Lorazepam and fMRI
Clinical Study IdentifierNCT04004416
SponsorUniversity of Michigan
Last Modified on25 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1, with history of psychosis, or other specified/unspecified psychotic disorder; or, meets Structured Interview for Psychosis Syndromes (SIPS) criteria for Presence of Psychotic Symptoms or Brief Intermittent Psychotic Syndrome (BIPS)
Ability and willingness to give informed consent to participate
-25 years old
Positive symptom onset 2 years
No history of active substance use disorder in the past 2 months
Not currently on an involuntary treatment order
Not taking chronic narcotics, barbiturates, benzodiazepines
Absence of suicidal thoughts with plans or intentions, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
No changes in psychotropic medication within the prior 4 weeks and for half of EP sample, or not taking antipsychotic medication within the prior 4 weeks. Patients may take as needed doses of benzodiazepines as clinically prescribed, as long as those doses are not required within 5 half-lives of an MRI session
Ability to tolerate small, enclosed spaces without anxiety
No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF)shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 pounds (lbs), men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
Exclusion
If a woman of child bearing age, not pregnant or trying to become pregnant
History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
Schizophrenia/schizoaffective and bipolar disorder patients
Inclusion Criteria
Ability and willingness to give informed consent to participate
- 60 years old
Meets DSM- 5 criteria for schizophrenia, or schizoaffective disorder (SCZ), or bipolar disorder type 1, with history of psychosis bipolar affective disorder (BAD)
Duration of positive symptom onset > 2 years
No history of active substance use disorder in the past 2 months
Not currently on an involuntary treatment order
Not taking chronic narcotics, barbiturates, benzodiazepines
Absence of suicidal thoughts with plans or intentions, as assessed by C-SSRS
No changes in psychotropic medication within the prior 4 weeks. Patients may take as needed doses of benzodiazepines as clinically prescribed, as long as those doses are not required within 5 half-lives of an MRI session
Ability to tolerate small, enclosed spaces without anxiety
No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, CSF shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
Exclusion
If a woman of child bearing age, not pregnant or trying to become pregnant
History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
Healthy control subjects
Inclusion Criteria
Ability and willingness to give informed consent to participate
Age 16 - 60
No history of (h/o) past or current mental illness (except for simple phobias), but prior h/o substance abuse ok if in remission for greater than 5 years
Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)
No first-degree family members with a history of a psychotic disorder (including bipolar disorder)
Ability to tolerate small, enclosed spaces without anxiety
No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, CSF shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
Exclusion
If a woman of child bearing age, not pregnant or trying to become pregnant
History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
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