Schizophrenia brain study probes Drug-Free brain activity
NCT ID NCT00001247
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 10 times
Summary
This completed study looked at how the brains of people with schizophrenia work when they are not taking antipsychotic medication. The goal was to tell apart the effects of the illness itself from the effects of the drugs. 648 participants stayed in a hospital and underwent brain scans and tests while temporarily stopping their medication under close medical supervision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could help separate the brain changes caused by schizophrenia from those caused by antipsychotic medications, leading to better understanding of the disease.
- What could go wrong
- This is an observational study, not a treatment trial. It involves temporarily stopping medication, which may worsen symptoms. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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648 people
The number who actually took part.
- Started
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Sep 1989
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals with schizophrenia-spectrum illness from the community.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Diagnosis of DSM-IV- or DSM5-defined schizophrenia spectrum disorder (including schizophrenia, schizoaffective disorder, or other specified/unspecified schizophrenia spectrum and other psychotic disorder/psychosis NOS). Subjects with other neuropsychiatric disorders may also be admitted and participate in the protocol if there is sufficient evidence to believe they have an underlying, undiagnosed DSM-IV-or DSM5-defined schizophrenia spectrum disorder. EXCLUSION CRITERIA: -Currently treated with depot medications Because of the long half-life of depot medications such as paliperidone palmitate (Invega Sustenna), applicants to our program will be excluded if they are currently receiving depot medications monthly. However, applicants may decide to switch from depot to oral medications on their own, in conjunction with their personal physician, before coming to the program. This is not part of research and we do not participate in this decision. A sufficient washout period based on the particular long-acting injectable medication s elimination half-life will be required in order for prospective participants to be eligible. Subjects may complete the last 3 months of washout in the inpatient unit while being evaluated under the standard protocol. -Major medical illness. Research subjects identified as having major medical problems other than their primary neuropsychiatric disorder will be excluded from admission. * Applicants judged to be unsuitable for medication free studies will also be excluded. Possible reasons for exclusion include prior history of dangerousness to self or others, particularly when off medication. * Applicants who are pregnant are excluded from this study. Volunteers who are found to be pregnant after testing will be terminated from study and referred to an OB-GYN for follow up care. * Infection with syphilis, hepatitis, or HIV. * History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence). * Cumulative lifetime history of any (excepting nicotine-related and cannabis-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months. * Lack of capacity to provide consent. Exclusion Criteria for Previously Enrolled Research Subjects * No longer satisfying the above inclusion criteria or meeting any of the above exclusion criteria * Inability to safely participate in planned research (e.g., development of acute suicidal behavior during prior research participation) * Unlikely to provide sufficient additional research data
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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