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Home > "T" Clinical Trials Conditions > Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)  Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
For Condition: Autoimmune Diseases,Mental Disorders Diagnosed in Childhood,Schizophrenia
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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 pupura. 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 10
Location and Contact Information:
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980014; 98-M-0014
Study Start Date: October 21, 1997
Record last reviewed: December 4, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001768
Other Schizophrenia Studies:
1. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
2. Study of Silicone-Associated Connective Tissue Diseases
3. Safety and Efficacy Study of LJP 394 (abetimus sodium) to treat lupus kidney disease
4. Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
5. Study of Oral Bacteria in Patients with Dry Mouth
Related Studies:
Other Schizophrenia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
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