High Dose Risperidone Consta for Patients With Schizophre... | NCT00539071

NCT00539071

Status Module

Sponsor/Collaborators Module

Name	Class
Ortho-McNeil Janssen Scientific Affairs, LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional dose	Active Comparator	All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.Any oral risperidone the patients receive will be discontinued after Week 4.At Week 6, psychopathology will be assessed with a PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.	Drug: long-acting injectable risperidone Drug: long acting injectable risperidone, Conventional Dose Group
High Dose group	Active Comparator	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4.Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.	Drug: long-acting injectable risperidone Drug: long acting injectable risperidone, High Dose Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
long-acting injectable risperidone	Drug	Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.	The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.	six months

Secondary Outcomes

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) Positive Scale	Positive and Negative Syndrome Scale (PANSS) Positive scale: Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time	six months
Positive and Negative Syndrome Scale (PANSS) Negative Scale

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with schizophrenia or schizoaffective disorder
Able to give written informed consent.
Moderate psychosis persists although compliant with medication
Patients must have an inadequate response to two antipsychotic medications (can be risperidone, oral or long acting - but not required), at doses that are within the upper end of the standard dosage range
Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity and a Personal and Social Performance Scale (PSP) score of 60 or below.
At the time of screening, eligible patients will be receiving or have received treatment with risperidone oral or Consta, or a combination that does not exceed 50 mg q 2 weeks of Consta or oral risperidone 8 mg/day for at least 6 weeks within seven years of study entry without satisfactory response as documented in the medical record Risperidone
Patients who have received Consta injectable medication within the specified dose range for no more than a month prior to the onset of the study will be eligible. Patients receiving mood stabilizers or antidepressants, or both, in addition to risperidone oral or Consta, will be eligible
Patients may initially be inpatients or outpatients
Females of childbearing potential will be admitted only if they are on stable birth control medication and understand that they should not get pregnant during the course of the study.
All patients must have stable housing at the current time or plans for housing following hospital discharge, if an inpatient.
Patients must be willing to receive injectable medication

Exclusion Criteria:

Patients with a diagnosis other than schizophrenia or schizoaffective disorder.
Patients previously treated with doses of these agents higher than those allowed for at least six months and who failed to have an adequate response will be excluded
Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 3 months
Pregnant females. Females who are currently breastfeeding will be excluded.
Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment.
Patient with worse than mild tardive dyskinesia or history of marked Extrapyramidal Symptoms (EPS) at screening
Patients who have had neuroleptic malignant syndrome
Patients with a history of galactorrhea
Patients with uncontrolled medical condition(s)
Patients with a history of non-compliance to oral or injectable medication.
Patients unwilling to have injectable medication

Contacts/Locations Module

Name	Affiliation	Role
Herbert Meltzer, M.D.	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Psychiatric Hospital		Nashville	Tennessee	37212-8645	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection). Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection). long-acting injectable risperidone, Conventional Dose Group: The study dose remains 50 mg for the length of the study.
BG001	High Dose Group	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. long-acting injectable risperidone, High Dose Group: Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00082 BG00178 BG002160

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00039.2± 10.6 BG00141± 11.4 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00122 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0016 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00082 BG00178 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.

The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms.

patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder

Posted

Mean

Standard Error

score on a scale

six months

ID	Title	Description
OG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
OG001	High Dose Group	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.

Units	Counts
Participants	OG00082 OG00178

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00089.0± 1.2 OG00189.7± 1.3

6 Weeks

Title	Measurements
	OG000

Secondary

Positive and Negative Syndrome Scale (PANSS) Positive Scale

Positive and Negative Syndrome Scale (PANSS) Positive scale:

Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time

patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder

Posted

Mean

Standard Error

score on a scale

six months

ID	Title	Description
OG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
OG001	High Dose Group	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.

Secondary

Positive and Negative Syndrome Scale (PANSS) Negative Scale

Positive and Negative Syndrome Scale (PANSS) Negative scale:

Consists of sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time

patients who met DSM-IV criteria for schizophrenia or schizoaffective disorder

Posted

Mean

Standard Error

score on a scale

six months

ID	Title	Description
OG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections. Oral risperidone will be discontinued after Week 4. At Week 6, psychopathology will be assessed with PANSS. Dose will remain at 50 mg q 2 weeks for those in the conventional Consta dose group.
OG001	High Dose Group	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections. Any oral risperidone the patients receive will be discontinued after Week 4. Psychopathology will be assessed with a PANSS at Week 6. If no improvement since baseline, dose will be increased to two 50 mg injections q 2 weeks for the remainder of the study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Conventional Dose	All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks (given as two injections - active 50 mg plus placebo injection).As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 3 unless symptoms warrant a quicker titration) along with the injections.	0	82	2	82	14	82
EG001	High Dose Group	Those who are randomized to high dose Consta will receive Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose after consent. As advised by the package insert for Consta, oral risperidone will be given (3-4 mg qd x 3 days followed by 6mg qd up to Week 4 unless symptoms warrant a quicker titration) along with the injections.	0	78	5	78	13	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Extrapyramidal	Nervous system disorders		Systematic Assessment	Minimal extrapyramidal side effects	EG0002 events2 affected82 at risk EG0015 events5 affected78 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Non-Serious Adverse Events	General disorders		Non-systematic Assessment	total	EG00019 events14 affected82 at risk EG00119 events13 affected78 at risk

Title	Organization	Phone	Extension	Email
Dr. Herbert Meltzer	Northwestern University	(312) 503-0309		h-meltzer@northwestern.edu

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D044382	Population Groups

ID	Term
D003710	Demography
D011154	Population Characteristics