Lorazepam and fMRI for Psychosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Michigan, Ann Arbor, MI
Psychosis+10 More
Lorazepam and fMRI - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

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

See full description

Eligible Conditions

  • Psychosis
  • Schizophrenia
  • Major Depression With Psychotic Features
  • Schizoaffective Disorders
  • Schizophreniform Disorders
  • Healthy Subjects (HS)
  • Manic Disorder

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Lorazepam and fMRI will improve 1 primary outcome in patients with Psychosis. Measurement will happen over the course of 2 hours after ingestion of lorazepam/placebo.

Hour 2
Blood Oxygen level dependent (BOLD) in medial frontal cortex while viewing affective pictures

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Bipolar disorder patients
1 of 4
Schizophrenia or Schizoaffective disorder patients
1 of 4
Early Psychosis patients
1 of 4
Healthy Controls
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 232 total participants across 4 different treatment groups

This trial involves 4 different treatments. Lorazepam And FMRI is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Bipolar disorder patients
Schizophrenia or Schizoaffective disorder patients
Early Psychosis patients
Healthy Controls

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours after ingestion of lorazepam/placebo
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 hours after ingestion of lorazepam/placebo for reporting.

Who is running the study

Principal Investigator
S. F. T.
Prof. Stephan F. Taylor, Professor of Psychiatry
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Meets DSM5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1, with history of psychosis, major depressive disorder, with history of psychosis, or other specified/unspecified psychotic disorder; or, meets SIPS criteria for Presence of Psychotic Symptoms or Brief Intermittent Psychotic Syndrome (BIPS).
Ability and willingness to give informed consent to participate;
Positive symptom onset ≤ 2 years
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 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)
16-35 years old

Patient Q&A Section

What are common treatments for mental disorders?

"The vast majority of people with mental disorders receive a combination of different treatment approaches, although the methods and combinations vary greatly. For example, the most common approach was medication alone for depression, but in addition many patients with depression use cognitive behavioural therapy, or some combination of both approaches." - Anonymous Online Contributor

Unverified Answer

What are the signs of mental disorders?

"The major signs of mental disorders in children are mood disturbances, inattention, behavioural difficulties, and anxiety.\n\nCNS: \n\nWhat are the signs of the nervous system?\n\nCNS signs include changes in personality and behaviour, difficulty concentrating and poor memory.\n\nCNS signs include abnormal movements, abnormal coordination, loss of sense of smell (anosmia), double vision, headaches, unsteadiness and tiredness.\n\nNCCN recommends against the routine use of screening for cancer in general population in all adults without symptoms and recommendations also exists for patients with risk factors for the development of cancer." - Anonymous Online Contributor

Unverified Answer

What is mental disorders?

"Different types of mental disorders exist; however, there are four major categories to name. These major types are mental illness, personality disorder, developmental disorder, and neurological disorder.\n" - Anonymous Online Contributor

Unverified Answer

What causes mental disorders?

"Mental disorders are influenced by a number of factors including genetics, the environment, and experience with and reaction to mental illness and drug use. There is no single cause of mental illness, but a combination of factors affect the development of mental disorder." - Anonymous Online Contributor

Unverified Answer

How many people get mental disorders a year in the United States?

"Mental disorders are [most frequent in American adult populations--3.7% of all people annually]--and are [even higher in Hispanic/Latino and African-American populations]--so the prevalence rates for mental disorders within the United States should be measured and adjusted to eliminate racial discrimination. Researchers and practitioners, especially in primary care settings are using mental disorder rates to improve the quality of care for their patients and to quantify the mental health needs of Americans." - Anonymous Online Contributor

Unverified Answer

Can mental disorders be cured?

"There is no medical research data to prove any of the cure proposals scientifically sound. In a recent study, findings presented show that a cure can be realized only after many years of treatment and with great care." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of lorazepam and fmri?

"The following side effects happened more often in patients prescribed with lorazepam than with diazepam: ataxia, tremor, somnolence, confusion, dry mouth, dizziness, fatigue, tachycardia, hypotension, and depression. Most of us did not know that lorazepam and fluvoxamine, which are both atypical antidepressants, could cause side effects similar to benzodiazepine's side effects." - Anonymous Online Contributor

Unverified Answer

How serious can mental disorders be?

"In the United States mental disorders are not necessarily fatal, but many persons with mental disorders do not receive treatment and tend to remain untreated. This leads others to believe that mental disorders are not serious illnesses. Serious consequences and a longer life span are possible." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in lorazepam and fmri for therapeutic use?

"We present the most up-to-date findings of our studies to date. In a recent study, findings are in line with those presented at an ILDG-AIMS Meeting in April 2003 (https://web.archive.org/web/20050903002641/http://www.ildgasim.com/2003), and at the World Conference 2003 (https://www.worldhealth.net/clinical-practice/journal/issues/index.aspx?articleId=4201), and may have implications for the treatment of chronic alcohol dependence." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of mental disorders?

"There are differences of the prevalence of the mental disorders depending of gender, age and educational level. In our study we found out that alcoholism causes the strongest mental disorders in women younger and older than 40 years while the main mental disorder cause was anxiety. Depression and schizophrenia are more common among men younger and older than 40 years." - Anonymous Online Contributor

Unverified Answer

How does lorazepam and fmri work?

"A significant increase in response to task-modality stimuli occurs after single intravenous doses of lorazepam. This effect is blunted by administration of a second dose of lorazepam. Lorazepam seems to work by altering processing of mental information during the course of a task in terms of response speed and reaction time, indicating that psychopharmacology might alter neural substrates during cognitive tasks." - Anonymous Online Contributor

Unverified Answer

Has lorazepam and fmri proven to be more effective than a placebo?

"The current study suggests that lorazepam was significantly more effective than a placebo in reducing anxiety levels in patients with insomnia. This is evident in all subjective assessments of insomnia symptoms and the EDSS score." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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