Back to resultsA Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Zolodine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding;
- Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
- Patients with refractory schizophrenia;
- Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
- Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
- Patients who use long-acting antipsychotic injections or oral medications;
- Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
- Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
- At the same time taking other drugs that can cause obesity, such as oral contraceptives;
- Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zolodine group
Arm Description
Outcomes
Primary Outcome Measures
score of PANSS
the score of positive and negative syndrome scale (PANSS), the minimum and maximum values are 16 and 112, the higher scores mean a worse outcome.
score of HAMA
the score of Hamilton anxiety scale(HAMA), the minimum and maximum values are 0 and 56, the higher scores mean a worse outcome.
score of HAMD
the score of Hamilton depression scale(HAMD), the minimum and maximum values are 0 and 68, the higher scores mean a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT04975035
First Posted
June 20, 2021
Last Updated
July 13, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04975035
Brief Title
A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
Official Title
A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
January 1, 2012 (undefined)
Primary Completion Date
July 1, 2012 (Actual)
Study Completion Date
July 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
5. Study Description
Brief Summary
Through self-controlled studies on metabolic syndrome related indicators, efficacy and other adverse reactions in patients with schizophrenia who developed metabolic syndrome after treatment with other antipsychotics, switched to Zoladine capsules (ziprasidone hydrochloride capsules). To evaluate the clinical application value of switching to Zolodine for schizophrenia patients with metabolic syndrome, and to explore the drug selection strategy for long-term treatment of schizophrenia patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zolodine group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zolodine
Intervention Description
Collect 200 patients who meet the criteria into the group. After enrollment, according to the principle of cross dressing change, the attending physician can decide the dressing change method according to the patient's condition, individual condition and other factors; within 2-4 weeks, the original antipsychotics should be gradually stopped, and Zoladine capsules will be gradually added to the target The dose is 120-160mg/d, orally 1-2 times a day, with meals.
Primary Outcome Measure Information:
Title
score of PANSS
Description
the score of positive and negative syndrome scale (PANSS), the minimum and maximum values are 16 and 112, the higher scores mean a worse outcome.
Time Frame
2 weeks
Title
score of HAMA
Description
the score of Hamilton anxiety scale(HAMA), the minimum and maximum values are 0 and 56, the higher scores mean a worse outcome.
Time Frame
2 weeks
Title
score of HAMD
Description
the score of Hamilton depression scale(HAMD), the minimum and maximum values are 0 and 68, the higher scores mean a worse outcome.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.
Exclusion Criteria:
Female patients who are pregnant or breastfeeding;
Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
Patients with refractory schizophrenia;
Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
Patients who use long-acting antipsychotic injections or oral medications;
Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
At the same time taking other drugs that can cause obesity, such as oral contraceptives;
Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
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