SchizophreniaPhase 4GABAmechNCT04004416
Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis
A Phase 4 study testing Lorazepam and fMRI in people with Schizophrenia and Bipolar Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Healthy
- What is being tested?
- Lorazepam and fMRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 28 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ability and willingness to give informed consent to participate;
- 16-35 years old
- Meets DSM5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1, with history of psychosis, major depressive disorder, with history of psychosis, brief psychotic disorder, or other specified/unspecified psychotic disorder; or, meets SIPS criteria for Presence of Psychotic Symptoms or Brief Intermittent Psychotic Syndrome (BIPS).
- Positive symptom onset ≤ 2 years
- No history of active substance use disorder in the past 2 months
- Not currently on an involuntary treatment order
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- 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 increases in psychotropic medication within the prior 4 weeks reflecting clinical instability and for half of the EP sample, 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 fMRI session
- Ability to tolerate small, enclosed spaces without anxiety
- Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- 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 difficulty fitting into the fMRI scanner properly.
- Ability and willingness to give informed consent to participate;
- 16- 60 years old
- Meets DSM5 criteria for schizophrenia, schizoaffective disorder, other specified/unspecified psychotic disorder, or bipolar disorder type 1, with history of psychosis bipolar affective disorder
- 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 Columbia-Suicide Severity Rating Scale (C-SSRS)
- No increases in psychotropic medication within the prior 4 weeks reflecting clinical instability. 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 fMRI session
- Ability to tolerate small, enclosed spaces without anxiety
- Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- 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 difficulty fitting into the fMRI scanner properly.
- Ability and willingness to give informed consent to participate
- 18- 60 years old
- No history of (h/o) past or current mental illness (except for simple phobias), but prior h/o substance abuse okay 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
- Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- 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 difficulty fitting into the fMRI scanner properly.
Who cannot join
- If a woman of childbearing 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
- Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
- Schizophrenia/schizoaffective (SCZ) and bipolar affective disorder (BAD) patients:
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- If a woman of childbearing 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
- Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
- Healthy control subjects:
- If a woman of childbearing 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
- Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-modal Assessment of GABA Function in Psychosis
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 childbearing potential will have a urine pregnancy test.
Read the detailed description
- Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award number.
- Initial assessment(s) may be done via videoconference due to Covid.
- Conditions
- Schizophrenia, Bipolar Disorder, Healthy, Psychosis, Schizophreniform Disorders, Schizo Affective Disorder
- Being tested
- Placebo and fMRI, Lorazepam and fMRI
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo and fMRIOther
Also called inactive medication
There will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
Lorazepam and fMRIDrug
Also called Ativan
There will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam (assigned to one of two dose levels between subjects: 0.01 mg/kg or 0.02 mg/kg) will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Placebo comparator | Not described Receives: Other: Placebo and fMRI; Drug: Lorazepam and fMRI |
| Early Psychosis patients | Experimental | Not described Receives: Other: Placebo and fMRI; Drug: Lorazepam and fMRI |
| Schizophrenia or Schizoaffective disorder patients | Experimental | Not described Receives: Other: Placebo and fMRI; Drug: Lorazepam and fMRI |
| Bipolar disorder patients | Experimental | Not described Receives: Other: Placebo and fMRI; Drug: Lorazepam and fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures
Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series within an region of interest (ROI). The resulting values are in arbitrary units (AU) reflecting variance-normalized signal after temporal filtering and serial correlation correction, which removes absolute signal scaling. While AU values are not directly interpretable as percent signal change, they preserve relative differences in BOLD change across conditions and are appropriate for statistical comparison.
Measured: Approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start16 Jan 2020
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The two MRI sessions will be scheduled approximately 28 days apart. If you are a woman, we may need to schedule the scanning session to coincide with a certain phase of your menstrual cycle.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephan F. Taylor, University of Michigan
- Investigators
- Stephan Taylor, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004416
- Sponsor's protocol ID
- HUM00162597
- Other IDs
- R01MH118634-01
- Acronym
- GABAmech
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2019
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy. The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant. The consent form will include language indicating the intention to upload de-identified data into the central archive, and permission will be obtained from University of Michigan Institutional Review Board to do so. The budget includes a data manager to cover the costs of managing the data, building the data dictionary and harmonizing it with data structures.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Assessment of GABA Function in Psychosis
- ClinicalTrials.gov ID
- NCT04004416
- Acronym / sponsor ID
- GABAmech / HUM00162597
- Conditions
- Schizophrenia, Bipolar Disorder, Healthy, Psychosis, Schizophreniform Disorders, Schizo Affective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 childbearing potential will have a urine pregnancy test.
Detailed description
- Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award number.
- Initial assessment(s) may be done via videoconference due to Covid.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- The two MRI sessions will be scheduled approximately 28 days apart. If you are a woman, we may need to schedule the scanning session to coincide with a certain phase of your menstrual cycle.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Placebo comparator | Other: Placebo and fMRI, Drug: Lorazepam and fMRI |
| Early Psychosis patients | Experimental | Other: Placebo and fMRI, Drug: Lorazepam and fMRI |
| Schizophrenia or Schizoaffective disorder patients | Experimental | Other: Placebo and fMRI, Drug: Lorazepam and fMRI |
| Bipolar disorder patients | Experimental | Other: Placebo and fMRI, Drug: Lorazepam and fMRI |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (35 listed)
- Ability and willingness to give informed consent to participate;
- 16-35 years old
- Meets DSM5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1, with history of psychosis, major depressive disorder, with history of psychosis, brief psychotic disorder, or other specified/unspecified psychotic disorder; or, meets SIPS criteria for Presence of Psychotic Symptoms or Brief Intermittent Psychotic Syndrome (BIPS).
- Positive symptom onset ≤ 2 years
- No history of active substance use disorder in the past 2 months
Key exclusion criteria (17 listed)
- If a woman of childbearing 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
- Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo and fMRIAlso: inactive medicationThere will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. | Other | Bipolar disorder patients, Early Psychosis patients, Healthy Controls, Schizophrenia or Schizoaffective disorder patients |
| Lorazepam and fMRIAlso: AtivanThere will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam (assigned to one of two dose levels between subjects: 0.01 mg/kg or 0.02 mg/kg) will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. | Drug | Bipolar disorder patients, Early Psychosis patients, Healthy Controls, Schizophrenia or Schizoaffective disorder patients |
Primary outcome
Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures
Time frame: Approximately 28 days
Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series within an region of interest (ROI). The resulting values are in arbitrary units (AU) reflecting variance-normalized signal after temporal filtering and serial correlation correction, which removes absolute signal scaling. While AU values are not directly interpretable as percent signal change, they preserve relative differences in BOLD change across conditions and are appropriate for statistical comparison.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The PI will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy. The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant. The consent form will include language indicating the intention to upload de-identified data into the central archive, and permission will be obtained from University of Michigan Institutional Review Board to do so. The budget includes a data manager to cover the costs of managing the data, building the data dictionary and harmonizing it with data structures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Taylor, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorazepam and fMRI in people with Schizophrenia and Bipolar Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures (time frame: Approximately 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.