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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Sirolimus

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 648 participants
Start Date 1989-09-15

What the Registry Record Tells You About NCT00001247

The ClinicalTrials.gov registry entry for NCT00001247 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 648 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (199% higher). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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