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Inpatient Evaluation of Adults With Schizophrenia

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 387 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 11 words

    Publications: details revised at 4 of 4 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: * Diagnosis of DSM-IV- or DSM5-defined schizophrenia spectrum [...] neuropsychiatric disorder will be excluded from admission. * Applicants judged to be unsuitable for medication free studi [...] usness to self or others, particularly when off medication. * Applicants who are pregnant are excluded from this study. Vo [...] ed 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-rela [...] ance use disorder (or DSM-IV-defined substance dependence). * Cumulative lifetime history of any (except [...] [...]

  2. Minor

    36 amendments

    36 re-verifications since 2025-04-19, no change to tracked fields

    v351-v386

  3. Minor

    Interventions: Sirolimus (Drug)

    Study Status, Arms and Interventionsv350

  4. Minor

    Enrollment target: 642 to 648

    Study Status, Study Designv349

  5. Minor

    6 amendments

    6 re-verifications since 2025-02-21, no change to tracked fields

    v343-v348

Show 5 earlier versions

  1. Minor

    Trial status: Recruiting to Completed

    Enrollment target: estimated 700 to confirmed 642; Site details revised

    Study Status, Study Design, Contacts/Locations, Referencesv342

  2. Minor

    4 amendments

    4 re-verifications since 2024-11-09, no change to tracked fields

    v338-v341

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to understand the biologic basis of schizophrenia and to determine which symptoms are related to the illness itself and which are related to medications used to treat the illness. Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure. Brain imaging technologies such s positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function. However, the use of anti-psychotic drugs may interfere with the results of such studies. In this study, psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medication's effects on the brain. Given that there is a risk that the patient's symptoms will increase, they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day. This study will be conducted in three phases. In Phase 1, participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews, physical and laboratory assessments, physiological monitoring, and neuropsychological testing. Behavioral ratings will also be performed and blood and urine samples will be collected. During Phase 2, participants will continue taking medications in a blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the continuation or lack of medication affects the brain. Psychological tests will also be given to measure changes in cognition. In Phase 3, participants will have the opportunity for clinical stabilization.
Trial Details
NCT Number NCT00001247
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions Schizophrenia
Enrollment 648 participants
Start Date
Updated on ClinicalTrials.gov