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

Sponsor

National Institute of Mental Health (NIMH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001768

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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

Primary Purpose:

Treatment

Official Title:

Childhood Onset Psychiatric Disorders: A Placebo Controlled Double-Blind Crossover Trial of Intravenous Immunoglobulin (IVIg)

Study Start Date :

Oct 1, 1997

Study Completion Date :

Jun 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.