NCT04076371

The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,640 (actual)
• Sponsor: Beijing HuiLongGuan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients

Detailed description

OBJECTIVE: This study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients METHODS: 1. atypical antipsychotics and dose: including four atypical antipsychotics to form eight treatment groups: 1) olanzapine (7.5-10mg/day) combined with sertraline (50-100mg/day) group 2) only olanzapine (12.5-20mg/day) group 3) risperidone (2-3.5mg/day) combined with sertraline (50-100mg/day) group 4) only risperidone (4-6mg/day) group 5) paliperidone (3-4.5mg/day) combined with sertraline (50-100mg/day) group 6) only paliperidone (6-9mg/day) group 7) ziprasidone (60-100mg/day) combined with sertraline (50-100mg/day) group 8) only ziprasidone (120-160mg/day) group 2. blood biochemical examination: including blood routine examination, liver function, renal function, thyroid function, glucose and lipid level, prolactin, and related hormones and proteins 3. electrophysiological examination: including electrocardiograph, electroencephalography (EEG), and brain evoked potential 4. scale assessment: each patient was assessed by four clinical psychiatrists using the following scales: 1) psychopathology: positive and negative symptoms scale (PANSS) and clinical global impression scale (CGI-S) 2) emotional symptoms: Hamilton depression rating scale (HAMD) and Hamilton anxiety rating scale (HAMA) 3) social function: personal and social performance scale (PSP) 4) side-effect: treatment emergent side-effect scale (TESS) and rating sale for extrapyramidal side-effect (RESES) 5. blood drug concentration assay: including the drug concentration of olanzapine, risperidone, paliperidone, ziprasidone and sertraline, respectively 6. Weigh gain measurement: to measure height, weight for each patient The above measurement data were collected at baseline, week4, week8, week 12 and week24.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	olanzapine-sertraline combination	the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
DRUG	only olanzapine	the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
DRUG	risperidone-sertraline combination	the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
DRUG	only risperidone	the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
DRUG	paliperidone-sertraline combination	the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
DRUG	only paliperidone	the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
DRUG	ziprasidone-sertraline combination	the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
DRUG	only ziprasidone	the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2019-09-03
• Last updated: 2019-09-03