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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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 groups in NCT00866645
Study groupRoleWhat they receive
1ExperimentalIntramuscular Levosulpiride
Receives: Drug: Intramuscular Levosulpiride
2Active comparatorIntramuscular Haloperidol
Receives: Drug: Intramuscular Haloperidol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change of PANSS-EC total scores

    Measured: from baseline to the end of study(72 hours after first dosing)

Secondary outcomes (7)

  1. the change of Agitation Calmness Evaluation Scale(ACES)

    Measured: from baseline to the end of study (72 hours after first dosing)

  2. 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)

  3. the change of PANSS total scores

    Measured: from baseline to the end of study (72 hours after first dosing)

  4. the change of Brief Psychiatric Rating Scale(BPRS) total scores

    Measured: from baseline to the end of study (72 hours after first dosing)

  5. the change of every item of PANSS-EC

    Measured: from baseline to the end of study (72 hours after first dosing)

  6. the change of Rating Scale for Extrapyramidal Side Effect(RSESE)

    Measured: from baseline to the end of study (72 hours after first dosing)

  7. 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.

  1. First posted20 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT00866645.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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