Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia

This study has been completed.

Study NCT00299702 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received on March 3, 2006. Last Updated on December 22, 2011 History of Changes

Results First Received: January 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Schizophrenia Psychotic Disorders
Interventions:	Drug: Abilify Drug: Risperidal Consta

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient in was on February 28, 2006; last patient out was on January 26, 2009. Enrollment occurred across multiple sites in the United States, Argentina, Chile, and India and patients were enrolled from outpatient psychiatric clinics associated with private medical practices, private clinical trial sites, and academic medical centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A Screening Visit (maximum of 14 days) prior to the Treatment Phase. Baseline included psychiatric exam, lab, ECG, and schizophrenia symptom rating scale. Subjects were permitted to remain on previous psychotropic medications (i.e., antipsychotic, antidepressant, mood stabilizer, anxiolytics) up to the first 4 weeks of the Treatment Phase.

Reporting Groups

	Description
Risperdal Consta	25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
Abilify	10-30 mg once daily oral for 104 weeks

Participant Flow: Overall Study

	Risperdal Consta	Abilify
STARTED	179	176
COMPLETED	126	126
NOT COMPLETED	53	50
Death	1	0
Adverse Event	0	4
Lost to Follow-up	18	10
Withdrawal by Subject	25	23
Pregnancy	0	1
Insufficient Response	4	3
Admin issues, sponsor decision, etc.	5	9

Baseline Characteristics

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Reporting Groups

	Description
Risperdal Consta	25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
Abilify	10-30 mg once daily oral for 104 weeks

Baseline Measures

	Risperdal Consta	Abilify	Total
Number of Participants [units: participants]	179	176	355
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	177	173	350
>=65 years	2	3	5
Age [units: years] Mean ± Standard Deviation	38.3 ± 11.66	37.8 ± 11.49	38 ± 11.56
Gender [units: participants]
Female	73	70	143
Male	106	106	212
Region of Enrollment [units: participants]
India	91	91	182
United States	51	52	103
South America	37	33	70

Outcome Measures

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1. Primary:

Time to Relapse [ Time Frame: Day 1 to relapse ]

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2. Primary:

Time in Remission [ Time Frame: Day 1 to last PANSS measurement ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
15% of subjects did not meet stability inclusion criteria; many received supplemental antipsychotics post-randomization; biweekly visits may have increased aripiprazole adherence; numerous early dropouts may have led to dependent censoring and bias.

Results Point of Contact:

Name/Title: Therapeutic Area Lead
Organization: Ortho-McNeil, Inc. N America Pharm CNS/IM
phone: 609-730-3693

No publications provided

Responsible Party:	Vice President, Medical Affairs, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00299702 History of Changes
Other Study ID Numbers:	CR006121, RISSCH4060
Study First Received:	March 3, 2006
Results First Received:	January 26, 2010
Last Updated:	December 22, 2011
Health Authority:	United States: Food and Drug Administration