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Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

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ClinicalTrials.gov Identifier: NCT02717130
Recruitment Status : Terminated (The study was terminated due to lack of enrollment.)
First Posted : March 23, 2016
Results First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
Washington University School of Medicine
University of Missouri-Columbia
University of Missouri, Kansas City
Burrell Behavioral Health
Information provided by (Responsible Party):
Florida Atlantic University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole (Abilify Maintena)
Hide Arm/Group Description Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Period Title: Overall Study
Started 8 [1]
Completed 1
Not Completed 7
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Physician Decision             1
Study Closure             4
[1]
Of the nine enrolled subjects, eight received study drug.
Arm/Group Title Aripiprazole (Abilify Maintena)
Hide Arm/Group Description Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
32.84  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Caucasian
2
  25.0%
African American
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Severity of Illness   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Moderately Ill
1
  12.5%
Markedly Ill
5
  62.5%
Severely Ill
2
  25.0%
[1]
Measure Description: The Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's psychiatric illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 corresponds to 'normal, not at all ill' patients while a rating of 7 corresponds to 'among the most extremely ill of patients'.
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per squared meter
Number Analyzed 8 participants
29.08  (7.88)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 8 participants
167.48  (13.40)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 8 participants
80.02  (16.36)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 8 participants
169.75  (32.38)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 8 participants
97.63  (58.34)
High-Density Lipoproteins (HDL) Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 8 participants
66.25  (33.97)
Low-Density Lipoproteins (LDL) Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 8 participants
84.13  (28.38)
Hemoglobin A1c (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 8 participants
5.11  (0.28)
1.Primary Outcome
Title Assessment of Hospital Re-admission in a 30 Day Time Frame
Hide Description Psychiatric re-hospitalization were planning to be assessed using hospital admission records. Study stopped due to lack of enrollment.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected. The number of participants analyzed is 0 because the study was stopped due to lack of enrollment.
Arm/Group Title Aripiprazole (Abilify Maintena)
Hide Arm/Group Description:
Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame The time period over which adverse event data were collected was 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole (Abilify Maintena)
Hide Arm/Group Description Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
All-Cause Mortality
Aripiprazole (Abilify Maintena)
Affected / at Risk (%)
Total   0/8 (0.00%)    
Hide Serious Adverse Events
Aripiprazole (Abilify Maintena)
Affected / at Risk (%) # Events
Total   3/8 (37.50%)    
General disorders   
Generalized weakness   1/8 (12.50%)  1
Nervous system disorders   
Seizure   1/8 (12.50%)  1
Psychiatric disorders   
Psychiatric hospitalization   1/8 (12.50%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole (Abilify Maintena)
Affected / at Risk (%) # Events
Total   6/8 (75.00%)    
Cardiac disorders   
Prolonged QTc Interval   1/8 (12.50%)  1
General disorders   
Sialorrhea   1/8 (12.50%)  1
Injection Site Pain   1/8 (12.50%)  1
Nervous system disorders   
Insomnia   1/8 (12.50%)  1
Akathisia   1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Cellulitis   1/8 (12.50%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: John W. Newcomer, M.D., President & CEO
Organization: Thriving Mind South Florida
Phone: 305-860-0653
EMail: jnewcomer@thrivingmind.org
Publications:
Layout table for additonal information
Responsible Party: Florida Atlantic University
ClinicalTrials.gov Identifier: NCT02717130    
Other Study ID Numbers: 031-104-0014
First Submitted: March 4, 2016
First Posted: March 23, 2016
Results First Submitted: March 26, 2020
Results First Posted: April 13, 2020
Last Update Posted: April 13, 2020