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Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg)

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ClinicalTrials.gov Identifier: NCT00001768
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Autoimmune Diseases Mental Disorders Diagnosed in Childhood Schizophrenia Drug: Intravenous immunoglobulin Phase 3

Detailed Description:
Recent developments in the study of early-onset obsessive-compulsive disorder (OCD) and Tourette's syndrome have implicated an autoimmune etiology in a subset of these conditions, and renewed interest into the possibility of autoimmune pathophysiology underlying other psychiatric disorders. There are several clinical and epidemiologic similarities between autoimmune diseases and schizophrenia: genetic predisposition, but with twin concordance below 50%; waxing and waning course; exacerbation of symptoms or precipitation of relapse by psychosocial stress. However, other mixed evidence has engendered considerable debate in the literature regarding the role of immune mechanisms in schizophrenia. The clinical efficacy and safety of intravenous immunoglobulin (IVIg) in immune-mediated neurological diseases has been documented, and clinical studies of the efficacy of IVIg in the treatment of both Tourette's syndrome and OCD are currently ongoing at the NIMH (see protocol 92-M-0132). In this protocol, we propose a 13-week placebo-controlled double-blind crossover study of IVIg in 25 patients suffering from treatment-refractory childhood-onset schizophrenia. After the first 5 patients have completed the trial, this data will be presented to the NIMH Institutional Review Board and a decision will be made as to whether this trial should proceed.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Primary Purpose: Treatment
Official Title: Childhood Onset Psychiatric Disorders: A Placebo Controlled Double-Blind Crossover Trial of Intravenous Immunoglobulin (IVIg)
Study Start Date : October 1997
Estimated Study Completion Date : June 2000


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients will be recruited from both professional referrals and patient advocacy sources, subject to medical and psychiatric screening.

Children and adolescents will be sought who meet DSM-III-R and DSM-IV criteria for schizophrenia, with onset of psychotic symptoms before age twelve, and who have no concurrent substance abuse disorders or other active medical conditions. In addition, they will have failed adequate trials of at least two typical neuroleptics, and not benefited from either olanzapine or clozapine.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001768


Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001768     History of Changes
Other Study ID Numbers: 980014
98-M-0014
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: December 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Autoimmunity
Childhood Onset Schizophrenia
Intravenous Gammaglobulin

Additional relevant MeSH terms:
Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Autoimmune Diseases
Problem Behavior
Neurodevelopmental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Immune System Diseases
Behavioral Symptoms
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs