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

Phase 1

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Zolodine

• Registration Number: NCT04975035
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2012-06
• Primary Completion: 2012-07-01
• Study Completion: 2012-07-01
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zolodine group	Zolodine	-

Primary Outcome Measures

Name	Time	Method
score of HAMD	2 weeks	the score of Hamilton depression scale(HAMD), the minimum and maximum values are 0 and 68, the higher scores mean a worse outcome.
score of PANSS	2 weeks	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	2 weeks	the score of Hamilton anxiety scale(HAMA), the minimum and maximum values are 0 and 56, the higher scores mean a worse outcome.