drugset / Trial / NCT04076371
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
RandomizedParallel-groupSingle-blindTreatment
Summary
A randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients
Timeline
- Start
- 2012-01
- Primary completion
- 2018-12
- Completion
- 2018-12
Publications
- Background 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.
- Background Ros LT. Treatment of postpsychotic depression with sertraline in patients with schizophrenia--own experience. Neuropsychopharmacol Hung. 2006 Oct;8(3):155-6.
- Background 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.
- Background 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.
- Background 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.
- Guan X, Xiu M, Wu F. Low-dose Olanzapine and Sertraline Combination Therapy for Metabolic Disturbance in Patients with Schizophrenia: A Large-scale, Open-label Randomized Trial. Curr Neuropharmacol. 2025 Nov 3. doi: 10.2174/011570159X395131251008050155. Online ahead of print.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 7.5 mg | — |
| Subject | Olanzapine | Small molecule | 10 mg | — |
| Subject | Olanzapine | Small molecule | 12.5 mg | — |
| Subject | Olanzapine | Small molecule | 20 mg | — |
| Subject | Paliperidone | Unknown | 3 mg | — |
| Subject | Paliperidone | Unknown | 4.5 mg | — |
| Subject | Paliperidone | Unknown | 6 mg | — |
| Subject | Paliperidone | Unknown | 9 mg | — |
| Subject | Risperidone | Other / unclassified | 2 mg | — |
| Subject | Risperidone | Other / unclassified | 3.5 mg | — |
| Subject | Risperidone | Other / unclassified | 4 mg | — |
| Subject | Risperidone | Other / unclassified | 6 mg | — |
| Subject | Sertraline | Small molecule | 50 mg | — |
| Subject | Sertraline | Small molecule | 100 mg | — |
| Subject | Ziprasidone | Small molecule | 60 mg | — |
| Subject | Ziprasidone | Small molecule | 100 mg | — |
| Subject | Ziprasidone | Small molecule | 120 mg | — |
| Subject | Ziprasidone | Small molecule | 160 mg | — |