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

NCT00001768 | Completed Phase 3

• 2 other identifiers: 98001498-M-0014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases; Mental Disorders Diagnosed in Childhood; Schizophrenia

Keywords

Autoimmunity; Childhood Onset Schizophrenia; Intravenous Gammaglobulin

Interventions

Intravenous immunoglobulin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Whitaker A, Johnson J, Shaffer D, Rapoport JL, Kalikow K, Walsh BT, Davies M, Braiman S, Dolinsky A. Uncommon troubles in young people: prevalence estimates of selected psychiatric disorders in a nonreferred adolescent population. Arch Gen Psychiatry. 1990 May;47(5):487-96. doi: 10.1001/archpsyc.1990.01810170087013.

  PMID: 2331210 BACKGROUND

• Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.

  PMID: 7661914 BACKGROUND

• Giedd JN, Rapoport JL, Leonard HL, Richter D, Swedo SE. Case study: acute basal ganglia enlargement and obsessive-compulsive symptoms in an adolescent boy. J Am Acad Child Adolesc Psychiatry. 1996 Jul;35(7):913-5. doi: 10.1097/00004583-199607000-00017.

  PMID: 8768351 BACKGROUND

MeSH Terms

Conditions

Autoimmune Diseases; Neurodevelopmental Disorders; Schizophrenia; Schizophrenia, Childhood

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Immune System Diseases; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: October 1, 1997
• Study Completion: June 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-12

Locations

US (1)