Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001768
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin IVIg
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Childhood Onset Psychiatric Disorders A Placebo Controlled Double-Blind Crossover Trial of Intravenous Immunoglobulin IVIg
Status:
COMPLETED
Status Verified Date:
1999-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent research studies of early onset-obsessive compulsive disorder OCD and Tourettes 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 Tourettes 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 bodys 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
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 Tourettes 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 bodys 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
Detailed Description:
Recent developments in the study of early-onset obsessive-compulsive disorder OCD and Tourettes 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 Tourettes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-M-0014 | None | None | None |