Trial Outcomes & Findings for Risperdal Consta for Bipolar Disorder (NCT NCT00177164)

NCT ID: NCT00177164

Last Updated: 2016-04-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Upto 15 months

Results posted on

2016-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Risperidone LAI Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Overall Study STARTED	23	25
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Risperidone LAI Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Overall Study Protocol Violation	0	7
Overall Study Lost to Follow-up	4	5
Overall Study increase in alcohol and drug use	1	2
Overall Study Adverse Event	1	0
Overall Study discharge from hospital	1	0
Overall Study Lack of Efficacy	2	1
Overall Study Pregnancy	0	1

Baseline Characteristics

Risperdal Consta for Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperidone LAI n=23 Participants Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP n=25 Participants Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder	Total n=48 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	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	25 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Upto 15 months

Population: 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.

Outcome measures

Outcome measures
Measure	Risperidone LAI n=23 Participants Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP n=25 Participants Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.	0.86 Number of clinical events Standard Deviation 0.73	1.61 Number of clinical events Standard Deviation 1.29

SECONDARY outcome

Timeframe: baseline to end of 15 months

Population: Patients with bipolar disorder

BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups

Outcome measures

Outcome measures
Measure	Risperidone LAI n=23 Participants Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP n=25 Participants Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
BMI Baseline	31.05 kg / m^2 Standard Deviation 7.20	29.86 kg / m^2 Standard Deviation 6.86
BMI Final	32.27 kg / m^2 Standard Deviation 8.31	32.0 kg / m^2 Standard Deviation 7.4

SECONDARY outcome

Timeframe: from baseline to end of 15 months

Population: patients with bipolar disorder

Number of participants with hyperglycemia based on safety labs

Outcome measures

Outcome measures
Measure	Risperidone LAI n=23 Participants Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP n=25 Participants Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Number of Participants With Treatment - Emergent Hyperglycemia	0 participants	0 participants

SECONDARY outcome

Timeframe: from baseline to end of 15 months

Population: patients with bipolar disorder

Number of participants with Hyperlipidemia as determined by safety labs

Outcome measures

Outcome measures
Measure	Risperidone LAI n=23 Participants Oral Risperidone followed by Long acting Risperidone injections (Consta) Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks	Oral AAP n=25 Participants Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Number of Participants With Treatment Emergent Hyperlipidemia	0 participants	0 participants

Adverse Events

Risperidone LAI

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Oral AAP

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

K.N. Roy Chengappa

UPMC

Phone: 412-246-5006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Risperidone LAI n=23 participants at risk	Oral AAP n=25 participants at risk
Metabolism and nutrition disorders Increased appetite	21.7% 5/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	28.0% 7/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Nervous system disorders Somnolence	26.1% 6/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	16.0% 4/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Metabolism and nutrition disorders Weight Gain	13.0% 3/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	20.0% 5/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Nervous system disorders Migraine Headache	17.4% 4/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	12.0% 3/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Musculoskeletal and connective tissue disorders tremors	17.4% 4/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Psychiatric disorders Halucinations	0.00% 0/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	16.0% 4/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Nervous system disorders Pain	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	12.0% 3/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Nervous system disorders akathesia	13.0% 3/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
General disorders skin rash	13.0% 3/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	0.00% 0/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
General disorders asthenia	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	12.0% 3/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Psychiatric disorders forgetfulness	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Respiratory, thoracic and mediastinal disorders URI	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
General disorders ademia	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	4.0% 1/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Nervous system disorders dizziness	4.3% 1/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Gastrointestinal disorders constipation	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	0.00% 0/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Renal and urinary disorders Urinary Incontinence	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	0.00% 0/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Reproductive system and breast disorders Menstrual distubances	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	0.00% 0/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Endocrine disorders Lactation	8.7% 2/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	0.00% 0/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Eye disorders blurred vision	0.00% 0/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Gastrointestinal disorders heartburn	0.00% 0/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	8.0% 2/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Endocrine disorders hyper glycemia	4.3% 1/23 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.	4.0% 1/25 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.