Schizophrenia Clinical Trial
Official title:
Childhood Onset Psychotic Disorders: Characterization and Treatment With Atypical Neuroleptics
The purpose of this study is to compare the effectiveness and side effects of the drugs
clozapine and olanzapine in children and adolescents with schizophrenia and psychoses.
Childhood psychosis is a serious disorder that may have devastating consequences. Effective
treatments for the condition are under continual investigation. This study will examine the
causes of and offer treatment for childhood psychosis.
Participants in this study will undergo psychological tests, blood and urine tests,
electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI)
scans of the brain for the first 1 to 2 weeks of the study while taking their regular
medications. Participants will then be tapered off their medications over 1 to 3 weeks and
will continue to stay off medications for an additional 2 days to 3 weeks. During this time,
participants will undergo psychiatric, neurological, and cardiac examinations as well as
blood tests. After this period without medications, participants will be randomly assigned
to receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to
treatment and after 6 weeks of study medication. Participants who respond well to the study
drugs may continue to receive them through their own physician. Participants who do not
respond to either clozapine or olanzapine or cannot tolerate their side effects will be
treated individually with other drugs until optimum treatment is identified. Regular
telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.
The purpose of this protocol is to compare efficacy of clozapine and olanzapine in children
and adolescents with schizophrenia and psychoses, as well as to learn about side effects of
these medication in pediatric population. The underlying hypothesis is that clozapine has
superior efficacy over olanzapine.
Children and adolescents, ages 7 to 18 years, meeting DSM-IV criteria for schizophrenia,
schizoaffective disorder and psychotic disorder not otherwise specified, with onset of
psychosis before their 13th birthday, who have not responded to at least two prior trials
with typical or a typical neuroleptics, will be eligible to participate in a double-blind,
parallel group, trial of olanzapine-clozapine.
This study will be done in conjunction with the Screening protocol, which will include
characterization by clinical phenomenology, eye tracking, MRI brain imaging, plasma
biochemistry, and chromosomal analysis.
This study will consist of the following phases 1) Tapering of psychotropic medications (1-4
weeks, depending upon type and dosage). 2) Observation for up to 2 weeks drug free, in order
to establish a baseline prior to starting medication trial. 3) An 8 week double-blind trial
of either clozapine or olanzapine. Efficacy and tolerability of clozapine and olanzapine
will be compared using specified criteria. 4) If desired improvement not achieved or trial
is interrupted, an 8 week open trial of the second medication and 5) Discharge following
medication optimization for up to 4 weeks, or as clinically appropriate. This protocol also
includes a follow-up every 2 to 3 years for a period of 10 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |