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

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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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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