Schizophrenia Clinical Trial
Official title:
Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine
Verified date | July 2011 |
Source | Taipei Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
Clozapine has been virtually the only psychopharmacological choice in patients with
schizophrenia who either did not response to typical neuroleptics or experienced severe
extrapyramidal side effects and consequently did not tolerate this medication. There are
patients who do not respond to clozapine, and the need to treat these severely ill patients
frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical
basis. One strategy is the combination of various other somatic treatments with clozapine.
Recently, the investigators conduct a preliminary open trial to evaluate the safety and
efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic
patients. The combined treatment is well tolerated, and clinical improvement is observed in
our patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight
gain and metabolic disturbance. However, the effects of fluvoxamine on the safety and
therapeutic efficacy of clozapine need to be further clarified in double-blind study.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Inpatients meet the DSM-IV criteria for schizophrenia. 2. Treatment refractoriness: Failed to respond to at least two typical neuroleptics at dosage equivalent to or greater than 1000 mg/day of chlorpromazine for a period of at least six weeks. 3. Age 18-60 years. 4. Males or females. 5. Total PANSS score >60 6. Good physical health determined by complete physical examination, laboratory tests, and EKG. 7. Capacity and willingness to give written informed consent. Exclusion Criteria: 1. History of illicit substance abuse or dependence 2. History of clozapine intolerance (such as clinically significant leukopenia or agranulocytosis). 3. Patients with WBC count less than 3500/mm3 or ANC count less than 2000/mm3will not be included. 4. Any depot neuroleptics within 30 days before the day of randomization. 5. Epilepsy, active hepatitis, HIV positivity, or current myeloproliferative disorder. Other medical illnesses may necessitate subjects' exclusion after evaluation of individual cases by the principal investigator and other staffs. Clinical judgment will be used. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University-Wan Fang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University Hospital | National Health Research Institutes, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the changes in the psychopathology during the trial | The changes in the scores of psychopathology assessment (the Positive and Negative Syndrome Scale, PANSS) | every 2 weeks | No |
Primary | the changes in the metabolic syndrome parameters during the trial | The changes in the metabolic syndrome parameters | every 2 weeks | Yes |
Secondary | the changes in the plasma drug levels | the plasma levels of fluvoxamine, clozapine, and its metabolites | every 2 weeks | No |
Secondary | The changes in insulin levels | The changes in insulin levels | every 2 weeks | Yes |
Secondary | The changes in the depression severity | The changes in the scores of the Hamilton Rating Scale for Depression | every 2 weeks | No |
Secondary | The changes in the adipokine levels | The changes in the adipokine levels | every 2 weeks | No |
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 |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
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 |