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NCT00001247 · ClinicalTrials.gov registry record
Inpatient Evaluation of Adults With Schizophrenia
A clinical trial of Schizophrenia, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 648
- Enrollment target
- 1
- Study location
NCT00001247: Completed study of Schizophrenia, sponsored by National Institute of Mental Health (NIMH).
NCT00001247 is a study of Schizophrenia that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 648 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (199% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001247, a study of Schizophrenia, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 648 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To map the physiological fMRI BOLD response, the brain electrical activity through MEG response and the blood flow, presynaptic and post-synaptic dopaminergic function through PET studies during different cognitive tasks
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 648 participants |
| Start Date | 1989-09-15 |
What the finished NCT00001247 record still lists
NCT00001247 is an observational study that tracks outcomes without assigning an intervention. The registered 648 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (199% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT00001247 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001247 about?
NCT00001247 is a clinical study titled "Inpatient Evaluation of Adults With Schizophrenia". 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 p...
What is the current status of trial NCT00001247?
This trial is currently completed. The enrollment target is 648 participants. The study started on 1989-09-15.
What conditions does trial NCT00001247 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00001247?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00001247?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001247 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001247's enrollment target sits among peer trials
648 22nd of 315 higher than 294 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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