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Risperdal Consta for Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00177164
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 8, 2016
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar I Disorder
Intervention Drug: Injectable Risperidone (Consta) or oral antipsychotic
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 23 25
Completed 14 9
Not Completed 9 16
Reason Not Completed
Protocol Violation             0             7
Lost to Follow-up             4             5
increase in alcohol and drug use             1             2
Adverse Event             1             0
discharge from hospital             1             0
Lack of Efficacy             2             1
Pregnancy             0             1
Arm/Group Title Risperidone LAI Oral AAP Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 23 25 48
Hide Baseline Analysis Population Description
Two patients in the Risperidone LAI group were not included in the analysis as they did not receive any assessment after the baseline assessment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
25
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Female
16
  69.6%
18
  72.0%
34
  70.8%
Male
7
  30.4%
7
  28.0%
14
  29.2%
[1]
Measure Description: 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.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  26.1%
3
  12.0%
9
  18.8%
White
16
  69.6%
22
  88.0%
38
  79.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.3%
0
   0.0%
1
   2.1%
[1]
Measure Description: 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.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 48 participants
23 25 48
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Upto 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: Number of clinical events
0.86  (0.73) 1.61  (1.29)
2.Secondary Outcome
Title BMI
Hide Description BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups
Time Frame baseline to end of 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with bipolar disorder
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: kg / m^2
Baseline 31.05  (7.20) 29.86  (6.86)
Final 32.27  (8.31) 32.0  (7.4)
3.Secondary Outcome
Title Number of Participants With Treatment - Emergent Hyperglycemia
Hide Description Number of participants with hyperglycemia based on safety labs
Time Frame from baseline to end of 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients with bipolar disorder
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Hyperlipidemia
Hide Description Number of participants with Hyperlipidemia as determined by safety labs
Time Frame from baseline to end of 15 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients with bipolar disorder
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Risperidone LAI Oral AAP
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Risperidone LAI Oral AAP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone LAI Oral AAP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risperidone LAI Oral AAP
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   25/25 (100.00%) 
Endocrine disorders     
Lactation  2/23 (8.70%)  0/25 (0.00%) 
hyper glycemia  1/23 (4.35%)  1/25 (4.00%) 
Eye disorders     
blurred vision  0/23 (0.00%)  2/25 (8.00%) 
Gastrointestinal disorders     
constipation  2/23 (8.70%)  0/25 (0.00%) 
heartburn  0/23 (0.00%)  2/25 (8.00%) 
General disorders     
skin rash  3/23 (13.04%)  0/25 (0.00%) 
asthenia  2/23 (8.70%)  3/25 (12.00%) 
ademia  2/23 (8.70%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Increased appetite  5/23 (21.74%)  7/25 (28.00%) 
Weight Gain  3/23 (13.04%)  5/25 (20.00%) 
Musculoskeletal and connective tissue disorders     
tremors  4/23 (17.39%)  2/25 (8.00%) 
Nervous system disorders     
Somnolence  6/23 (26.09%)  4/25 (16.00%) 
Migraine Headache  4/23 (17.39%)  3/25 (12.00%) 
Pain  2/23 (8.70%)  3/25 (12.00%) 
akathesia  3/23 (13.04%)  2/25 (8.00%) 
dizziness  1/23 (4.35%)  2/25 (8.00%) 
Psychiatric disorders     
Halucinations  0/23 (0.00%)  4/25 (16.00%) 
forgetfulness  2/23 (8.70%)  2/25 (8.00%) 
Renal and urinary disorders     
Urinary Incontinence  2/23 (8.70%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Menstrual distubances  2/23 (8.70%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
URI  2/23 (8.70%)  2/25 (8.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: K.N. Roy Chengappa
Organization: UPMC
Phone: 412-246-5006
Responsible Party: K.N. Roy Chengappa, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177164     History of Changes
Other Study ID Numbers: RIS-PSY-405
Univ. Pittsburgh IRB #0403091
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 7, 2016
Results First Posted: February 8, 2016
Last Update Posted: April 19, 2016