Physostigmine for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Connecticut Mental Health Center, New Haven, CT
Schizophrenia+1 More
Physostigmine - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors

See full description

Eligible Conditions

  • Schizophrenia
  • Smoking

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Physostigmine will improve 2 primary outcomes in patients with Schizophrenia. Measurement will happen over the course of first 120 min scan at baseline, second 120 scan 2.5 hours after amphetamine administration.

Hour 5
Change in DA levels at baseline and after amphetamine administration as confirmed by PET images.
first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration
Change in ACh levels at baseline and after physostigmine administration as confirmed by PET images.

Trial Safety

Side Effects for

Lorazepam
Vomitnig
10%
Oversedation
10%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03090620) in the Lorazepam ARM group. Side effects include: Vomitnig with 10%, Oversedation with 10%.

Trial Design

1 Treatment Group

physostigmine and amphetamine
1 of 1
Experimental Treatment

This trial requires 130 total participants across 1 different treatment group

This trial involves a single treatment. Physostigmine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

physostigmine and amphetamine
Drug
There is only one arm to the study. All subjects will receive physostigmine and amphetamine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amphetamine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration for reporting.

Closest Location

Connecticut Mental Health Center - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who can read and write. show original
People who are able to give their voluntary, written agreement after being informed about the study. show original
Women of childbearing age who participate in this study must use an acceptable method of birth control, as determined by the principal investigator show original
They have no uncontrolled medical conditions that would affect their neurological, cardiovascular, endocrine, renal, liver or thyroid health. show original
They have no history of neurological or psychiatric disorders other than schizophrenia in the schizophrenia subgroup. show original
The participants in the study have not regularly used any prescription, herbal or illegal psychotropic medications in the past 6 months. show original
Schizophrenic subjects have not used any herbal or illegal substances in the past 6 months show original
I have not used marijuana in the past 30 days and I have not met the criteria for dependence in the past 2 years. show original
, consume 1,200 mg/day If you are female and not pregnant or breastfeeding, you should consume 1,200 mg/day. show original
The recommended amount of alcohol that people should consume per week is less than 21 drinks for women and less than 35 drinks for men. show original

Patient Q&A Section

What are the signs of schizophrenia?

"Schizophrenia is associated with poor vision and hearing, which may make it hard to see or hear people who are not speaking. It may also affect cognition, which can also limit people with schizophrenia. Depression and cognitive problems, such as hallucinations, are associated with poor treatment completion in those with schizophrenia. In those with early signs of schizophrenia, such as poor hearing or vision, there is also increased risk of poor outcomes. We discuss some of the issues that lead to these findings." - Anonymous Online Contributor

Unverified Answer

What causes schizophrenia?

"Some researchers argue that a single genetic defect will not cause schizophrenia with 100% consistency of research studies reporting different risk factors, and it is argued that schizophrenia is a complex disorder. But as no single factor has been identified as being solely responsible for the occurrence of schizophrenia, this view remains a matter of controversy." - Anonymous Online Contributor

Unverified Answer

Can schizophrenia be cured?

"Whilst no cure for schizophrenia exists, recent developments in the field of neuroscience in conjunction with cognitive behavioral therapy and antipsychotic drugs have made psychosis alleviation possible in select cases." - Anonymous Online Contributor

Unverified Answer

How many people get schizophrenia a year in the United States?

"The American Association of Community Psychiatrists estimate that about 70 million people over age 20 will have schizophrenia at some time in their lives. If these estimates are correct, they present new challenges to community psychiatrists who must deal with high levels of social stigma, public misinformation, and patient-providers' ignorance of the illness." - Anonymous Online Contributor

Unverified Answer

What are common treatments for schizophrenia?

"What are common treatments for schizophrenia? The common and useful treatments include antipsychotic medications, mood stabilizers and antidepressants. In addition, cognitive behavioral therapy (CBT), family therapy, community programs, social networks, and social skills training (SST) are common methods used in the treatment of schizophrenia." - Anonymous Online Contributor

Unverified Answer

What is schizophrenia?

"Schizophrenia is a mental illness with a wide range of symptoms that involves impaired judgement and beliefs and can become disabling in about half of those treated. Symptoms typically begin by the age of 20 to 25. Schizophrenia was thought to be rare or nonexistent in the 1890s but is now prevalent in low socioeconomic areas and affects about 1 to 2% of Europeans. People affected typically have severe and sometimes debilitating symptoms and significant social stigma. Topics covered include what is schizophrenia, causes, risk factors, treatments, and signs and symptoms." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets schizophrenia?

"Average age at onset was 20.2 for early onset, and 24.9 for late onset. Both tended to be more frequent in females than male, but the sex difference was only statistically significant for early onset." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving physostigmine?

"This is the first time that PHY has been tested in a clinical scale in patients with schizophrenia. Despite a slight rise in P3 amplitude, our data suggest that the current test doesn't correlate with actual changes on the schizophrenic phenotype in the treated patients. Thus, we can deduce that further studies are still needed to be conducted in order to establish whether PHY has any additional effects in patients suffering from schizophrenia. This project has been funded through the Italian Ministry of Defence (Ministro dello Stato.it) Special Programme for Education and Research\n\nThis project has been funded by the Italian Ministry of Defence (Ministro dello Stato." - Anonymous Online Contributor

Unverified Answer

How does physostigmine work?

"The current experimental results suggest that the anticholinergic effects of physostigmine may be mediated in part by its action on GABA(A) receptors, which are involved in the modulation of anxiety. The anticholinergic properties of physostigmine suggest that it may act to reduce anxiety by inhibiting the excitatory GABAergic process in the central nervous system." - Anonymous Online Contributor

Unverified Answer

Does physostigmine improve quality of life for those with schizophrenia?

"A physiostigmine dose of 120 mg/d improves QOL in the area of health perception and participation in social/leisure pursuits in this patient group over 2 months. Although a placebo-controlled trial would be required to confirm these results, we suggest that physiostigmine warrants further investigation in this patient group." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of physostigmine?

"No common side effects of physostigmine were observed. The risk of hypersensitivity reactions and allergic reactions in the case of physostigmine are exceedingly low. The risks can be avoided by the use of the lowest possible dosage. If needed when necessary, physostigmine should be rapidly reversed." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of schizophrenia?

"The first part of the study supports the hypothesis that a disorder of glutamate neurotransmission involving NMDA, AMPA receptors and other subunit types plays an important role in schizophrenia. However, the second part implies that the problem is multifactorial." - 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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