A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine

NCT ID: NCT04975035

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2012-07-01

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zolodine group

Group Type: EXPERIMENTAL

Zolodine

Intervention Type: DRUG

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.

Interventions

Zolodine

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2012-074

Identifier Type: -

Identifier Source: org_study_id