A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

This study has been completed.

Sponsor:

Information provided by:

Janssen Pharmaceutica N.V., Belgium

ClinicalTrials.gov Identifier:

NCT00391222

First received: October 20, 2006

Last updated: May 19, 2011

Last verified: May 2011

History of Changes

Results First Received: April 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Bipolar Disorder
Interventions:	Drug: Risperidone Long Acting Injectable (LAI) Drug: Olanzapine Drug: Placebo

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
This study was run from 14 November 2006 to 13 April 2009. Patients were recruited at 70 investigational sites located in 14 countries across Europe, Asia, Latin-America, and Africa.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were treated appropriately or continued previous treatment. At baseline, treatment with Risperidone Long Acting Injectable (LAI) was started. During 12 weeks patients were stabilized on risperidone LAI and treatment with antipsychotics, mood stabilizers and other psychotropics was titrated off unless otherwise specified in the protocol.

Reporting Groups

	Description
Risperidone LAI	Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
Placebo	Double-blind Period III: placebo injections every 14 days and oral placebo daily
Olanzapine	Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Open-label Risperidone LAI	Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days

Participant Flow for 2 periods

Period 1: Period II (Open-label Risperidone LAI)

	Risperidone LAI	Placebo	Olanzapine	Open-label Risperidone LAI
STARTED	0	0	0	560 ^[1]
COMPLETED	0	0	0	398
NOT COMPLETED	0	0	0	162
Withdrawal by Subject	0	0	0	26
Lost to Follow-up	0	0	0	5
Adverse Event	0	0	0	10
Non-responder	0	0	0	97
Unknown	0	0	0	24

[1]	The 25 patients at the site of Dr. Parikh were excluded from the analysis due to GCP non-compliance

Period 2: Period III (Double-Blind Treatment)

	Risperidone LAI	Placebo	Olanzapine
STARTED	132 ^[1]	135 ^[1]	131 ^[1]
COMPLETED	104	113	108
NOT COMPLETED	28	22	23
Withdrawal by Subject	15	12	6
Lost to Follow-up	2	4	4
Adverse Event	5	2	4
Pregnancy	0	2	0
Study Medication Non-compliant	0	1	3
Unknown	6	1	6

[1]	Patients were randomized to one of 3 arms in Period III, after completing open-label Period II

Baseline Characteristics

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Reporting Groups

	Description
Risperidone LAI	Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
Placebo	Double-blind Period III: placebo injections every 14 days and oral placebo daily
Olanzapine	Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
Total	Total of all reporting groups

Baseline Measures

	Risperidone LAI	Placebo	Olanzapine	Total
Number of Participants [units: participants]	132	135	131	398
Age [units: years] Mean ± Standard Deviation	35.76 ± 11.23	36.87 ± 11.08	36.57 ± 11.10	36.41 ± 11.12
Gender [units: participants]
Female	78	71	59	208
Male	54	64	72	190

Outcome Measures

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1. Primary:

Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo) [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 1

2. Secondary:

Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 2

3. Secondary:

Time to Recurrence of a Depressive Episode [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 3

4. Secondary:

Time to Early Study Discontinuation for Any Reason [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 4

5. Secondary:

Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS) [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 5

6. Secondary:

Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 6

7. Secondary:

Time to Recurrence of a Mood Episode (Exploratory/Olanzapine) [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

Show Outcome Measure 7

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
No text entered.

Results Point of Contact:

Name/Title: EMEA Medical Affairs Director
Organization: Janssen Cilag Spain
phone: +34 91 7228043

No publications provided

Responsible Party:	EMEA Medical Affairs Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier:	NCT00391222 History of Changes
Obsolete Identifiers:	NCT01205113
Other Study ID Numbers:	CR012145
Study First Received:	October 20, 2006
Results First Received:	April 19, 2010
Last Updated:	May 19, 2011
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

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