The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
NCT ID: NCT04076371
Last Updated: 2019-09-03
Study Results
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Basic Information
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COMPLETED
NA
1640 participants
INTERVENTIONAL
2012-01-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
Interventions
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olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 60 years and Han Chinese
Exclusion Criteria
* 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)
18 Years
60 Years
ALL
No
Sponsors
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Beijing HuiLongGuan Hospital
OTHER
Responsible Party
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Xiang Yang Zhang
Professor
Principal Investigators
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Xiaoe Lang, Doctor
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Shanxi Medical University
References
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Mulholland C, Lynch G, King DJ, Cooper SJ. A double-blind, placebo-controlled trial of sertraline for depressive symptoms in patients with stable, chronic schizophrenia. J Psychopharmacol. 2003 Mar;17(1):107-12. doi: 10.1177/0269881103017001713.
Ros LT. Treatment of postpsychotic depression with sertraline in patients with schizophrenia--own experience. Neuropsychopharmacol Hung. 2006 Oct;8(3):155-6.
Poyurovsky M, Kurs R, Weizman A. Olanzapine-sertraline combination in schizophrenia with obsessive-compulsive disorder. J Clin Psychiatry. 2003 May;64(5):611. doi: 10.4088/jcp.v64n0518c. No abstract available.
Bogers JPAM, Schulte PFJ, Broekman TG, Moleman P, de Haan L. Dose reduction of high-dose first-generation antipsychotics or switch to ziprasidone in long-stay patients with schizophrenia: A 1-year double-blind randomized clinical trial. Eur Neuropsychopharmacol. 2018 Sep;28(9):1024-1034. doi: 10.1016/j.euroneuro.2018.06.005. Epub 2018 Jul 17.
Takekita Y, Koshikawa Y, Fabbri C, Sakai S, Sunada N, Onohara A, Nishida K, Yoshimura M, Kato M, Serretti A, Kinoshita T. Cognitive function and risperidone long-acting injection vs. paliperidone palmitate in schizophrenia: a 6-month, open-label, randomized, pilot trial. BMC Psychiatry. 2016 May 29;16:172. doi: 10.1186/s12888-016-0883-9.
Lang X, Xue M, Zang X, Wu F, Xiu M, Zhang X. Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naive patients with schizophrenia: a randomized controlled open-label study. J Transl Med. 2023 Jul 4;21(1):432. doi: 10.1186/s12967-023-04272-7.
Lang X, Zang X, Yu F, Xiu M. Effects of low-dose combined olanzapine and sertraline on negative and depressive symptoms in treatment-resistant outpatients with acute exacerbated schizophrenia. Front Pharmacol. 2023 Apr 21;14:1166507. doi: 10.3389/fphar.2023.1166507. eCollection 2023.
Shi H, Xu J, Lang X, Wu HE, Xiu MH, Zhang XY. Comparison of Efficacy and Safety Between Low-Dose Ziprasidone in Combination With Sertraline and Ziprasidone Monotherapy for Treatment-Resistant Patients With Acute Exacerbation Schizophrenia: A Randomized Controlled Trial. Front Pharmacol. 2022 Apr 26;13:863588. doi: 10.3389/fphar.2022.863588. eCollection 2022.
Zhu C, Guan X, Wang Y, Liu J, Kosten TR, Xiu M, Wu F, Zhang X. Low-Dose Ziprasidone in Combination with Sertraline for First-Episode Drug-Naive Patients with Schizophrenia: a Randomized Controlled Trial. Neurotherapeutics. 2022 Apr;19(3):1037-1046. doi: 10.1007/s13311-022-01242-7. Epub 2022 Apr 25.
Chen YQ, Li XR, Zhang L, Zhu WB, Wu YQ, Guan XN, Xiu MH, Zhang XY. Therapeutic Response Is Associated With Antipsychotic-Induced Weight Gain in Drug-Naive First-Episode Patients With Schizophrenia: An 8-Week Prospective Study. J Clin Psychiatry. 2021 May 11;82(3):20m13469. doi: 10.4088/JCP.20m13469.
Other Identifiers
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CASPsy3
Identifier Type: -
Identifier Source: org_study_id
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