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NCT00001768 · ClinicalTrials.gov registry record · Phase 3
Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg)
A Phase 3 study of Schizophrenia and Autoimmune Diseases, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00001768 is a Phase 3 study of Schizophrenia and Autoimmune Diseases that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 10 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001768, a Phase 3 study of Schizophrenia and Autoimmune Diseases, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's syndrome have questioned whether autoimmunity could play a role in the development of these conditions. As a result, there has been an increased interest in the field of research on the potential involvement of autoimmunity in other psychiatric conditions like schizophrenia. Autoimmune conditions occur when the normal immune system of the body begins working against itself. The immune system recognizes cells as foreign and begins to attack them. There are several similarities between autoimmune diseases and schizophrenia. Genetics play some role in the development of both diseases. Both conditions show a similar course, and both conditions tend to show worsening of symptoms when exposed to stress. Previous research studies have shown intravenous immunoglobulin to be safe and effective when used in neurologic diseases involving the immune system. Presently the NIMH is testing the effectiveness of IVIg in OCD and Tourette's syndrome. Intravenous Immunoglobulin IVIg is a medication that has been used to treat diseases like Kawasaki disease, systemic juvenile rheumatoid arthritis, lupus nephritis, and idiopathic thrombocytopenic purpura. The drug modifies the body's natural immune reactions. This research study is a 13-week trial of intravenous immunoglobulin (IVIg) on patients suffering from childhood-onset schizophrenia, who have failed to respond to other therapies.
Conditions Studied
Interventions
- DRUG Intravenous immunoglobulin
Study Locations (1)
Maryland
- National Institute of Mental Health (NIMH) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 1997-10 |
| Est. Completion | 2000-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001768
The ClinicalTrials.gov registry entry for NCT00001768 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10 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 (95% 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 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Intravenous immunoglobulin is the first listed.
NCT00001768 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001768 about?
NCT00001768 is a clinical study titled "Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg)". Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's syndrome have questioned whether autoimmunity could play a role in the development of these conditions. As a result, there has been an increased interest in the field of research on the potential involvement of...
What is the current status of trial NCT00001768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 1997-10. Estimated completion is 2000-06.
What conditions does trial NCT00001768 study?
This clinical trial studies the following conditions: Schizophrenia, Autoimmune Diseases, Mental Disorders Diagnosed in Childhood.
What interventions are being tested in trial NCT00001768?
The interventions under investigation include: Intravenous immunoglobulin (DRUG).
Who is sponsoring clinical trial NCT00001768?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001768 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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