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

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ClinicalTrials.gov Identifier: NCT04076371
Recruitment Status : Completed
First Posted : September 2, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: olanzapine-sertraline combination Drug: only olanzapine Drug: risperidone-sertraline combination Drug: only risperidone Drug: paliperidone-sertraline combination Drug: only paliperidone Drug: ziprasidone-sertraline combination Drug: only ziprasidone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
Drug: olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
Other Name: olanzapine-sertraline

Placebo Comparator: only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
Drug: only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)

Experimental: risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
Drug: risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
Other Name: risperidone-sertraline

Placebo Comparator: only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
Drug: only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)

Experimental: paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
Drug: paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
Other Name: paliperidone-sertraline

Placebo Comparator: only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
Drug: only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)

Experimental: ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
Drug: ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
Other Name: ziprasidone-sertraline

Placebo Comparator: only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
Drug: only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076371


Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Investigators
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Study Director: Xiaoe Lang, Doctor First Hospital of Shanxi Medical University

Publications:
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Responsible Party: Xiang Yang Zhang, Professor, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT04076371     History of Changes
Other Study ID Numbers: CASPsy3
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
schizophrenia
sertraline
olanzapine
risperidone
paliperidone
ziprasidone
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Paliperidone Palmitate
Ziprasidone
Sertraline
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists