Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161018
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2005-09-08
Brief Title:
New Antipsychotic Strategies Quetiapine and Risperidone vs Fluphenazine in Treatment Resistant Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The purpose of this study is to
1 Evaluate the efficacy and safety of the new antipsychotics quetiapine 300-500mgday and risperidone 3-4mgday compared to each other and to fluphenazine 10-15mgday a high potency typical antipsychotic in patients who meet the DSM IV criteria for schizophrenia
2 To evaluate the efficacy and safety of quetiapine 1200mgday in patients who have not responded to conventional and newer antipsychotics
3 To evaluate the effectiveness of quetiapine 300-500mgday and risperidone 3-5mgday compared to each other and fluphenazine 10-15mgday in the treatment of hostility and aggression in treatment-resistant schizophrenic patients
4 To evaluate the effectiveness of quetiapine 300-500mgday and risperidone 3-5mgday compared to each other and fluphenazine 10-15mgday on rates of discharge quality of life and independent living skills
5 To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities
6 To evaluate the possible differential impact of treatment conditions on cognitive functioning including measures of attention motor speed problem solving verbal and visual memory and verbal processing speed
7 To measure changes in weight and health consequences associated with weight changes
1 Evaluate the efficacy and safety of the new antipsychotics quetiapine 300-500mgday and risperidone 3-4mgday compared to each other and to fluphenazine 10-15mgday a high potency typical antipsychotic in patients who meet the DSM IV criteria for schizophrenia
2 To evaluate the efficacy and safety of quetiapine 1200mgday in patients who have not responded to conventional and newer antipsychotics
3 To evaluate the effectiveness of quetiapine 300-500mgday and risperidone 3-5mgday compared to each other and fluphenazine 10-15mgday in the treatment of hostility and aggression in treatment-resistant schizophrenic patients
4 To evaluate the effectiveness of quetiapine 300-500mgday and risperidone 3-5mgday compared to each other and fluphenazine 10-15mgday on rates of discharge quality of life and independent living skills
5 To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities
6 To evaluate the possible differential impact of treatment conditions on cognitive functioning including measures of attention motor speed problem solving verbal and visual memory and verbal processing speed
7 To measure changes in weight and health consequences associated with weight changes
Detailed Description:
This is a three arm multi-center randomized double-blind study After open label treatment with each individual being optimized with routine antipsychotic treatment for 4-6 weeks to prospectively establish lack of response to conventional antipsychotic therapy approximately 180 patients with schizophrenia who are experiencing clinically significant psychotic symptoms will be recruited minimum 150 enrolled in the double-blind period of the study All participants will sign consent forms before participating in this research study If participants choose to enroll in the high dose quetiapine arm period IIIb they will sign an additional consent form before entering period IIIb
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