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

Beijing HuiLongGuan Hospital

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: risperidone-sertraline combination; Drug: olanzapine-sertraline combination; Drug: only risperidone; Drug: only ziprasidone; Drug: only paliperidone; Drug: only olanzapine; Drug: ziprasidone-sertraline combination; Drug: paliperidone-sertraline combination

Study type: Interventional

Funder types: Other

Identifiers

NCT04076371

CASPsy3

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,640 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia by two senior psychiatrists
• Between 18 and 60 years and Han Chinese

Exclusion criteria

• A Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Axis I diagnosis other than schizophrenia
• Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
• Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,640 participants in 8 patient groups, including a placebo group

olanzapine-sertraline combination

Experimental group

Description:

the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)

Treatment:

Drug: olanzapine-sertraline combination

only olanzapine

Placebo Comparator group

Description:

the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)

Treatment:

Drug: only olanzapine

risperidone-sertraline combination

Experimental group

Description:

the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)

Treatment:

Drug: risperidone-sertraline combination

only risperidone

Placebo Comparator group

Description:

the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)

Treatment:

Drug: only risperidone

paliperidone-sertraline combination

Experimental group

Description:

the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)

Treatment:

Drug: paliperidone-sertraline combination

only paliperidone

Placebo Comparator group

Description:

the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)

Treatment:

Drug: only paliperidone

ziprasidone-sertraline combination

Experimental group

Description:

the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)

Treatment:

Drug: ziprasidone-sertraline combination

only ziprasidone

Placebo Comparator group

Description:

the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)

Treatment:

Drug: only ziprasidone