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Completed

NCT Number: NCT04076371

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

OBJECTIVE: This study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients

METHODS:

  • 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
  • blood biochemical examination: including blood routine examination, liver function, renal function, thyroid function, glucose and lipid level, prolactin, and related hormones and proteins
  • electrophysiological examination: including electrocardiograph, electroencephalography (EEG), and brain evoked potential
  • 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)
  • blood drug concentration assay: including the drug concentration of olanzapine, risperidone, paliperidone, ziprasidone and sertraline, respectively
  • Weigh gain measurement: to measure height, weight for each patient

The above measurement data were collected at baseline, week4, week8, week 12 and week24.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

olanzapine-sertraline combination

Drug

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

Other names: olanzapine-sertraline

only olanzapine

Drug

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

risperidone-sertraline combination

Drug

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

Other names: risperidone-sertraline

only risperidone

Drug

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

paliperidone-sertraline combination

Drug

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

Other names: paliperidone-sertraline

only paliperidone

Drug

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

ziprasidone-sertraline combination

Drug

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

Other names: ziprasidone-sertraline

only ziprasidone

Drug

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

Primary outcomes

  1. changes in psychopathology symptoms on PANSS during antipsychiatric treatment

    Time frame: baseline, week 4, week 8, week 12, and week 24

    The Positive and Negative Syndrome Scale (PANSS) is a well-characterized and widely applied dimensional assessment that reflects a balanced representation of positive and negative syndromes, their differential and general severity of illness. The scales not only measures positive and negative syndromes, but also suggests their differential and general severity of the illness. The items on the PANSS are defined with increasing levels from 1 to 7: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. Then the PANSS score is totaled by sum up the ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.

  2. changes in depressive symptoms on HAMD during antipsychiatric treatment

    Time frame: baseline, week 4, week 8, week 12, and week 24

    HAMD stands for Hamilton Rating Scale. It is the assessment that designed for examining the treatment significant of depression severity. The general format contains 17 items, 12 of them are scored from 0 to 4 while the rest of them ranges from 0 to 2. The items represented a variety of aspects: Depression mood, Feeling of guilt, Suicide, Insomnia early, Insomnia middle, Insomnia late, Work and activities, Motor retardation, Agitation, Psychic anxiety, Somatic anxiety, Somatic symptoms(gastrointestinal), somatic symptoms(general), Genital symptoms (sexual interest). Hypochondriasis, Weight loss and Insight. So A cut-off score less than or equal to 7 in the HAMD scale defines the symptomatic remission.

Secondary outcomes

  1. changes in electroencephalography examination for brain activity during antipsychiatric treatment

    Time frame: baseline, week 4, week 8, week 12, and week 24

    electroencephalography, or EEG is the physiological method of choice to record the electrical activity generated by the brain via electrodes placed on the scalp surface. For faster application, electrodes are mounted in elastic caps similar to bathing caps, ensuring that the data can be collected from identical scalp positions across all respondents. By analysis of frequency and amplitude of five kind of brain waves(delta, theta, alpha, beta, gamma) , we could detect the synchronized activity of neurons within cortical areas even at sub-second timescales

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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