Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients
OBJECTIVE: This study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients
METHODS:
The above measurement data were collected at baseline, week4, week8, week 12 and week24.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine-sertraline combination | Experimental | the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day) |
|
| only olanzapine | Placebo Comparator | the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day) |
|
| risperidone-sertraline combination | Experimental | the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day) |
|
| only risperidone | Placebo Comparator | the patient was prescribed moderate to severity dose of risperidone (4-6mg/day) |
|
| paliperidone-sertraline combination | Experimental | the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine-sertraline combination | Drug | the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in psychopathology symptoms on PANSS during antipsychiatric treatment | 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. | baseline, week 4, week 8, week 12, and week 24 |
| changes in depressive symptoms on HAMD during antipsychiatric treatment | 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. | baseline, week 4, week 8, week 12, and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in electroencephalography examination for brain activity during antipsychiatric treatment | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoe Lang, Doctor | The First Affiliated Hospital of Shanxi Medical University | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12680747 | 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. | |
| 17211050 | Background | Ros LT. Treatment of postpsychotic depression with sertraline in patients with schizophrenia--own experience. Neuropsychopharmacol Hung. 2006 Oct;8(3):155-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| only paliperidone |
| Placebo Comparator |
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day) |
|
| ziprasidone-sertraline combination | Experimental | the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day) |
|
| only ziprasidone | Placebo Comparator | the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day) |
|
|
| 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) |
|
|
| 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) |
|
|
| 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) |
|
|
| only ziprasidone | Drug | the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day) |
|
| baseline, week 4, week 8, week 12, and week 24 |
| 12755669 | 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. |
| 30025751 | 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. |
| 27236412 | 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. |
| 41185506 | Derived | 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. |
| 37403159 | Derived | 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. |
| 37153770 | Derived | 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. |
| 35559243 | Derived | 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. |
| 35467271 | Derived | 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. |
| 34004092 | Derived | 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. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided