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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076371
• Other study ID #: CASPsy3
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1640
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

References & Publications (5)

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. — View Citation

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. — View Citation

Poyurovsky M, Kurs R, Weizman A. Olanzapine-sertraline combination in schizophrenia with obsessive-compulsive disorder. J Clin Psychiatry. 2003 May;64(5):611. — View Citation

Ros LT. Treatment of postpsychotic depression with sertraline in patients with schizophrenia--own experience. Neuropsychopharmacol Hung. 2006 Oct;8(3):155-6. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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	baseline, week 4, week 8, week 12, and week 24