Trial Outcomes & Findings for Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder? (NCT NCT00571688)

Last Updated: 2017-07-31

Results Overview

The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score \> 14 or MADRS \> 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or intensive outpatient treatment) due to worsening mood symptoms; (4) a Clinical Global Impression Severity of Illness score \>3; (5) syndromal relapse (Diagnostic and Statistical Manual of Mental Disorders, 4th Editionfor manic, hypomanic, major depressive, or mixed episode met); (6) withdrawal from the study due to inefficacy; and (7) necessary clinical medication adjustments (NCAs).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

12 months

Results posted on

2017-07-31

Participant Flow

Referred by treating provider

Diagnostic review prior to randomization

Participant milestones

Participant milestones
Measure	Risperdal Consta Risperdal Consta injection in conjunction with existing treatment Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg intramuscularly (IM) every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.	Treatment As Usual Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
Overall Study STARTED	25	25
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Risperdal Consta Risperdal Consta injection in conjunction with existing treatment Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg intramuscularly (IM) every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.	Treatment As Usual Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
Overall Study Lost to Follow-up	3	6
Overall Study subject did not tolerate Consta	1	0
Overall Study subject moved out of the area	1	0

Baseline Characteristics

Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperdal Consta n=25 Participants Risperdal Consta injection in conjunction with existing treatment Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.	Treatment As Usual n=25 Participants Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.8 Years STANDARD_DEVIATION 8.7 • n=5 Participants	38.2 Years STANDARD_DEVIATION 10.2 • n=7 Participants	40.5 Years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All randomized participants were analyzed.

Outcome measures

Outcome measures
Measure	Risperdal Consta n=25 Participants Risperdal Consta injection in conjunction with existing treatment Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.	Treatment As Usual n=25 Participants Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
Number of Relapse-related Events Normalized to Unit Time	5.34 Events/month Standard Deviation 2.35	6.26 Events/month Standard Deviation 3.24

Adverse Events

Risperdal Consta

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment As Usual

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Risperdal Consta n=25 participants at risk Risperdal Consta injection in conjunction with existing treatment Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.	Treatment As Usual n=25 participants at risk Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
Nervous system disorders Sedation	12.0% 3/25 • Number of events 3 • 1 year Adverse effects spontaneously reported by participants.	16.0% 4/25 • Number of events 4 • 1 year Adverse effects spontaneously reported by participants.
Metabolism and nutrition disorders Weight gain	8.0% 2/25 • Number of events 2 • 1 year Adverse effects spontaneously reported by participants.	12.0% 3/25 • Number of events 3 • 1 year Adverse effects spontaneously reported by participants.

Additional Information

Tracy Manley

University of Alabama at Birmingham

Phone: 205-975-3442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place