Inpatient Evaluation of Adults With Schizophrenia

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Keywords

ClinConnect Summary

This clinical trial is studying schizophrenia, a chronic brain disorder that affects how people think and behave. The main goal is to better understand the biological causes of schizophrenia and to figure out which symptoms are due to the illness itself and which are caused by the medications used to treat it. To do this, participants will temporarily stop their medications while staying in a safe hospital setting, allowing researchers to observe how the illness affects the brain without interference from the drugs.

Eligible participants are adults diagnosed with schizophrenia or related disorders, and they should not be currently receiving certain long-lasting medications. During the trial, participants will undergo various tests, including brain scans and psychological assessments, to monitor their symptoms and brain function. The trial has three phases, starting with evaluations while on medication, followed by a period where some may receive a placebo instead of their usual medication, and concluding with a focus on stabilizing their condition. Throughout the study, participants will have access to round-the-clock support from clinical staff to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• * 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

Trial Officials