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NCT00061789 · ClinicalTrials.gov registry record · Phase 2
Imaging of Brain Receptors in Healthy Volunteers and in Patients With Schizophrenia
A Phase 2 study of Schizophrenia, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00061789 is a Phase 2 study of Schizophrenia that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 100 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00061789, a Phase 2 study of Schizophrenia, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will use single photon emission computed tomography (SPECT) to study brain nicotine receptors (proteins on the surface of brain cells) in healthy subjects and in patients with schizophrenia. Autopsy findings in patients with schizophrenia show changes in their nicotine receptors. This study will use SPECT to look at these receptors in living schizophrenia patients and compare them with those in healthy subjects. The following individuals between 21 and 50 years of age (or between 21 and 80 years of age for Group 1 only) are eligible for this study: healthy non-smokers (Group 1); schizophrenia patients who smoke (Group 2); schizophrenia patients who do not smoke (Group 3); healthy smokers (Group 4); healthy non-smokers (Group 5). Patients with schizophrenia must be taking olanzapine (Zyprexa) or risperidone (Risperdal) for at least 6 months. All candidates will be screened at the first visit. Group 1 participants will have three more visits; Groups 2 through 5 will have two more visits. Visit 1 All participants will be screened with physical and neurological examinations; blood and urine tests; and neuropsychological tests to assess their ability to learn and remember words and numbers, to pay attention, and to quickly perform motor tasks, such as putting pegs into a piece of wood. In addition, they will have an eye movement test and event-related potential testing. For the eye test, the subject sits in a chair and leans forward with the chin on a chin rest. A band is tied around the head and very small amounts of invisible (infrared) light are shined into the eyes. The light is reflected back and measured. Wire electrodes are placed around the area of the eye and cheek to monitor eye blinks and eye movements. Subjects are asked to follow a light with their eyes and to look away from a light. For event- related potential testing, electrodes are placed on the scalp, forehead and cheeks, and brain activity is recorded while the subject identifies particul
Conditions Studied
Interventions
- DRUG SPECT Imaging of Nicotinic Acetylcholine Receptors in Brain
Study Locations (1)
Maryland
- National Institute of Mental Health (NIMH) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00061789
The ClinicalTrials.gov registry entry for NCT00061789 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower). 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 SPECT Imaging of Nicotinic Acetylcholine Receptors in Brain is the first listed.
NCT00061789 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00061789 about?
NCT00061789 is a clinical study titled "Imaging of Brain Receptors in Healthy Volunteers and in Patients With Schizophrenia". This study will use single photon emission computed tomography (SPECT) to study brain nicotine receptors (proteins on the surface of brain cells) in healthy subjects and in patients with schizophrenia. Autopsy findings in patients with schizophrenia show changes in their nicotine receptors. This stu...
What is the current status of trial NCT00061789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2003-02. Estimated completion is 2004-08.
What conditions does trial NCT00061789 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00061789?
The interventions under investigation include: SPECT Imaging of Nicotinic Acetylcholine Receptors in Brain (DRUG).
Who is sponsoring clinical trial NCT00061789?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00061789 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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Related
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