Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study

NCT03289026 | Completed Phase 4

• 1 other identifier: 320-57-1706-1101-0001
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 12

Brief Summary

This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.

Conditions

Acute Schizophrenia Episode

Keywords

Aripiprazole; Acute schizophrenia episode; positive symptoms

Outcome Measures

Primary Outcomes (3)

• PANSS (positive and negative symptoms scale) total score

  Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks

  baseline,8 weeks

• PANSS positive score

  Change from baseline PANSS positive score at 8 weeks

  baseline,8 weeks

• CGI-S (clinical general impression-severity)

  Change from baseline CGI-S (clinical general impression-severity) at 8 weeks

  baseline,8 weeks

Secondary Outcomes (2)

• PANSS negative score

  baseline,8 weeks

• MSQ (Medication Satisfaction Questionnaire)score

  baseline,8 weeks

Other Outcomes (7)

• Fasting blood lipids

  baseline,4,8 weeks

• Fasting blood glucose

  baseline, 4,8 weeks

• Serum prolactin

  baseline, 4,8 weeks

Study Arms (1)

aripiprazole group

EXPERIMENTAL

Patients receive aripiprazole treatment

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.

Also known as: Aripiprazole Orally Disintegrating Tablets; Bosiqing®

aripiprazole group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia.
• acute episode; inpatients
• PANSS total score at least 70
• scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score
• Written informed consent

You may not qualify if:

• other serious diseases;
• Pregnant or breast feeding women or planning a pregnancy
• Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect;
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Allergy to Aripiprazole
• History of alcohol or drug abuse or dependence in the past 1-year before screening
• mental retardation; bipolar disorder; major depressive disorder;
• Currently using one kind of antipsychotic drug at a dose that exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using two kinds of antipsychotic drugs, at least one of which reaches or exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using three kinds of antipsychotic drugs or more;
• Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course
• Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
• Patients with clinically significant abnormalities on liver function (ALT or AST\>2 times of higher limit of normal range)
• Patients who had Electroconvulsive Therapy (ECT) in the past 2 months
• Participation in a clinical trial of another drug within 4 weeks prior to study entry

Sponsors & Collaborators

• Peking University: lead

Study Sites (12)

The Fourth People's Hospital of Hefei

Hefei, Anhui, 230000, China

Location

Beijing Anding Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Haerbin Psychiatric Hospital

Harbin, Heilongjiang, 150056, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Wuhan Mental Health Center

Wuhan, Hubei, 430000, China

Location

102 Miltary Hospital of China

Changzhou, Jiangsu, 213003, China

Location

Shandong Mental Health Center

Jinan, Shandong, 250014, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200003, China

Location

The Fourth People's Hospital of Chengdu

Chengdu, Sichuan, 610036, China

Location

Hangzhou Seventh People's Hospital

Hanzhou, Zhejiang, 310013, China

Location

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: September 20, 2017
• Study Start: September 1, 2017
• Primary Completion: January 23, 2020
• Study Completion: February 2, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)