AgitationPhase 2/3NCT00866645
A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
A Phase 2/3 study testing Intramuscular Haloperidol and Intramuscular Levosulpiride in people with Agitation, run by Shanghai Mental Health Center at 5 sites in China.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Agitation
- What is being tested?
- Intramuscular Haloperidol and Intramuscular Levosulpiride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- Feb 2009to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Chinese inpatients(are required to stay at hospital during the study) aged 18-65 years
- Patients meeting the DSM-IV criteria for schizophrenia or schizophreniform psychosis
- Agitated with a minimum total score of ≧ 15 on the five items of the PANSS-EC and at least one individual item score of ≧ 5 or two item score of ≧ 4 using the 1-7 scoring system
- ACES≤3
- Written informed consent provided by patients' legal representative
Who cannot join
- Investigator and his/her relatives
- Participation in another drug trial within 3 months prior enrolment into this study
- Female patients during their pregnant and lactation period
- Any currently severe unstable medical illness or disease would affect assessment for this study, including epilepsy, angle closure glaucoma, disease of liver, kidney, gastrointestinal tract, respiratory system, cardiovascular system(including Ischemic Heart Disease), endocrine system, nervous system, immune or hematological system etc.
- A significantly clinical abnormal value in ECG or lab results,ALT and AST values in the liver function test exceeding two times of the upper limits of normal values, urea nitrogen value arising up to 1.2 times of the upper limits of normal values, creatinine or serum potassium exceeding normal values
- With a family history of sudden death
Show all 18Show fewer
- Meet the DSM-IV criteria for substance abuse within 1 year prior enrolment
- Regularly use antipsychotics(clozapine within 90 days), antidepressants, mood stabilizers, anti-epileptics or prolonged-action preparations within 2 weeks prior enrolment
- Use of Electroconvulsive therapy within 30 days prior enrolment
- Systematically use of sulpiride, levosulpiride or haloperidol therapy within 30 days prior enrolment
- History of or current neuroleptic malignant syndrome, severe EPS, significant tardive dyskinesia
- Severe suicide attempt
- Known hypersensitivity to sulpiride, levosulpiride or haloperidol, or history of severe drug hypersensitivity or hypersensitivity to more than 2 drugs
- Use of psychotropics(except permitted drugs) within 12 hours prior enrolment
- Known lack of efficacy to levosulpiride or haloperidol by formal treatment before
- Organic mental disorders, including Mental retardation
- History of psychosurgery treatment
- Patients can not comply with study protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hebei Mental Health Center
Baoding, Hebei, 071000
The First Affilliated Hospital Of Kunming Medical College
Kunming, Yunnan, 650032
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Xi'an Mental Health Center
Xi'an, Shaanxi, 710061
About this study
Official title: A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.
Read the detailed description
Secondary Outcome Measures:
To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: No ]
To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]
- Conditions
- Agitation
- Being tested
- Intramuscular Haloperidol, Intramuscular Levosulpiride
- Keywords
- Agitation, Schizophrenia, Randomized, Blind, Parallel, Intramuscular Haloperidol, Controlled, Multicenter, Clinical Trial, Efficacy, Safety, Intramuscular Levosulpiride, Chinese, PANSS-EC, ACES, CGI, BPRS, PANSS, RSESE, BAS
- Medical subject headings
- Psychomotor Agitation, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular HaloperidolDrug
Also called Intramuscular Haloperidol parenteral solution
1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.
Intramuscular LevosulpirideDrug
Also called Intramuscular Levosulpiride parenteral solution
2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intramuscular Levosulpiride Receives: Drug: Intramuscular Levosulpiride |
| 2 | Active comparator | Intramuscular Haloperidol Receives: Drug: Intramuscular Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of PANSS-EC total scores
Measured: from baseline to the end of study(72 hours after first dosing)
Secondary outcomes (7)
the change of Agitation Calmness Evaluation Scale(ACES)
Measured: from baseline to the end of study (72 hours after first dosing)
The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I)
Measured: from baseline to the end of study (72 hours after first dosing)
the change of PANSS total scores
Measured: from baseline to the end of study (72 hours after first dosing)
the change of Brief Psychiatric Rating Scale(BPRS) total scores
Measured: from baseline to the end of study (72 hours after first dosing)
the change of every item of PANSS-EC
Measured: from baseline to the end of study (72 hours after first dosing)
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
Measured: from baseline to the end of study (72 hours after first dosing)
the change of Barnes Akathisia Scale(BAS)
Measured: from baseline to the end of study (72 hours after first dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Hotmed Sciences Co.,LTD
- Investigators
- Huafang LI, MD,PhD, Study director, Drug Clinical Trial Office, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866645
- Sponsor's protocol ID
- 2004L03556
- Other IDs
- SMHC-100
- Status last verified
- Dec 2010
- First submitted
- 19 Mar 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia
- ClinicalTrials.gov ID
- NCT00866645
- Acronym / sponsor ID
- 2004L03556
- Conditions
- Agitation
- Keywords
- Agitation, Schizophrenia, Randomized, Blind, Parallel, Intramuscular Haloperidol, Controlled, Multicenter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Hotmed Sciences Co.,LTD
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.
Detailed description
Secondary Outcome Measures:
To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: No ]
To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intramuscular LevosulpirideIntramuscular Levosulpiride |
| 2 | Active comparator | Drug: Intramuscular HaloperidolIntramuscular Haloperidol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female Chinese inpatients(are required to stay at hospital during the study) aged 18-65 years
- Patients meeting the DSM-IV criteria for schizophrenia or schizophreniform psychosis
- Agitated with a minimum total score of ≧ 15 on the five items of the PANSS-EC and at least one individual item score of ≧ 5 or two item score of ≧ 4 using the 1-7 scoring system
- ACES≤3
- Written informed consent provided by patients' legal representative
Key exclusion criteria (18 listed)
- Investigator and his/her relatives
- Participation in another drug trial within 3 months prior enrolment into this study
- Female patients during their pregnant and lactation period
- Any currently severe unstable medical illness or disease would affect assessment for this study, including epilepsy, angle closure glaucoma, disease of liver, kidney, gastrointestinal tract, respiratory system, cardiovascular system(including Ischemic Heart Disease), endocrine system, nervous system, immune or hematological system etc.
- A significantly clinical abnormal value in ECG or lab results,ALT and AST values in the liver function test exceeding two times of the upper limits of normal values, urea nitrogen value arising up to 1.2 times of the upper limits of normal values, creatinine or serum potassium exceeding normal values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular HaloperidolAlso: Intramuscular Haloperidol parenteral solution1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days. | Drug | 2 |
| Intramuscular LevosulpirideAlso: Intramuscular Levosulpiride parenteral solution2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days. | Drug | 1 |
Primary outcome
the change of PANSS-EC total scores
Time frame: from baseline to the end of study(72 hours after first dosing)
7 secondary outcomes
the change of Agitation Calmness Evaluation Scale(ACES)
Time frame: from baseline to the end of study (72 hours after first dosing)
The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I)
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of PANSS total scores
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Brief Psychiatric Rating Scale(BPRS) total scores
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of every item of PANSS-EC
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Barnes Akathisia Scale(BAS)
Time frame: from baseline to the end of study (72 hours after first dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang LI, MD,PhD study director
Drug Clinical Trial Office, Shanghai Mental Health Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intramuscular Haloperidol and Intramuscular Levosulpiride in people with Agitation, run by Shanghai Mental Health Center at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of PANSS-EC total scores (time frame: from baseline to the end of study(72 hours after first dosing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.