NCT04076371

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,640

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

6.9 years

First QC Date

July 14, 2019

Last Update Submit

August 29, 2019

Conditions

Schizophrenia

Keywords

schizophreniasertralineolanzapinerisperidonepaliperidoneziprasidone

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • changes in electroencephalography examination for brain activity during antipsychiatric treatment

    baseline, week 4, week 8, week 12, and week 24

Study Arms (8)

olanzapine-sertraline combination

EXPERIMENTAL

the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)

Drug: olanzapine-sertraline combination

only olanzapine

PLACEBO COMPARATOR

the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)

Drug: only olanzapine

risperidone-sertraline combination

EXPERIMENTAL

the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)

Drug: risperidone-sertraline combination

only risperidone

PLACEBO COMPARATOR

the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)

Drug: only risperidone

paliperidone-sertraline combination

EXPERIMENTAL

the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)

Drug: paliperidone-sertraline combination

only paliperidone

PLACEBO COMPARATOR

the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)

Drug: only paliperidone

ziprasidone-sertraline combination

EXPERIMENTAL

the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)

Drug: ziprasidone-sertraline combination

only ziprasidone

PLACEBO COMPARATOR

the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)

Drug: only ziprasidone

Interventions

olanzapine-sertraline combinationDRUG

the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)

Also known as: olanzapine-sertraline
olanzapine-sertraline combination
only olanzapineDRUG

the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)

only olanzapine
risperidone-sertraline combinationDRUG

the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)

Also known as: risperidone-sertraline
risperidone-sertraline combination
only risperidoneDRUG

the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)

only risperidone
paliperidone-sertraline combinationDRUG

the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)

Also known as: paliperidone-sertraline
paliperidone-sertraline combination
only paliperidoneDRUG

the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)

only paliperidone
ziprasidone-sertraline combinationDRUG

the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)

Also known as: ziprasidone-sertraline
ziprasidone-sertraline combination
only ziprasidoneDRUG

the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)

only ziprasidone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia by two senior psychiatrists
  • Between 18 and 60 years and Han Chinese

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 12680747BACKGROUND

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

    PMID: 17211050BACKGROUND

  • 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.

    PMID: 12755669BACKGROUND

  • 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.

    PMID: 30025751BACKGROUND

  • 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.

    PMID: 27236412BACKGROUND

  • 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.

    PMID: 41185506DERIVED

  • 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.

    PMID: 37403159DERIVED

  • 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.

    PMID: 37153770DERIVED

  • 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.

    PMID: 35559243DERIVED

  • 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.

    PMID: 35467271DERIVED

  • 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.

    PMID: 34004092DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Xiaoe Lang, Doctor

    The First Affiliated Hospital of Shanxi Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2019

First Posted

September 3, 2019

Study Start

January 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share