The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Intervention name(s): olanzapine-sertraline combination; only olanzapine; risperidone-sertraline combination; only risperidone; paliperidone-sertraline combination; only paliperidone; ziprasidone-sertraline combination; only ziprasidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day); the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day); the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day); the patient was prescribed moderate to severity dose of risperidone (4-6mg/day); the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day); the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day); the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day); the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
Other intervention name(s): olanzapine-sertraline; risperidone-sertraline; paliperidone-sertraline; ziprasidone-sertraline
Intervention MeSH terms: Olanzapine; Risperidone; Paliperidone Palmitate; Ziprasidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; sertraline; olanzapine; risperidone; paliperidone; ziprasidone