Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (KISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02472652
Recruitment Status : Terminated (Lack of adequate enrollment)
First Posted : June 16, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Gazda, Thomas D., M.D., PC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sexual Dysfunction
Intervention Drug: Abilify Maintena
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abilify Maintena
Hide Arm/Group Description

Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.

Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Abilify Maintena
Hide Arm/Group Description

Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.

Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
ASEX (Arizona Sexual Experiences Scale)   [1] [2] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 1 participants
11
[1]
Measure Description: ASEX (Arizona Sexual Experiences Scale) score at baseline and end of study. This is a five item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm and satisfaction from orgasm. possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
[2]
Measure Analysis Population Description: Second subject lost to follow up
1.Primary Outcome
Title Change in Arizona Sexual Experiences Scale (ASEX) Score
Hide Description Subjects enrolled in this study will be followed for an average of about 5 months. The ASEX will be done at screening to ensure subjects meet criteria for sexual dysfunction as defined by the scale. In addition subjects must remember at least a 2 point change in the scale since starting Invega Sustenna or Risperdal Consta. Subjects must also score no greater than or equal to 25 on the scale to ensure a baseline of minimal sexual activity. The primary outcome of the study is the change in ASEX score from Baseline to Endpoint. Total scores range from 5 - 30 with the higher scores indicating more sexual dysfunction.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data no available for Subject 2 as lost to follow up
Arm/Group Title Abilify Maintena
Hide Arm/Group Description:

Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.

Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
11
2.Secondary Outcome
Title Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)
Hide Description Subjects enrolled in this study will be followed for an average of about 5 months. Serum prolactin concentrations will be measured to assess change from Baseline to Endpoint
Time Frame Baseline and Endpoint average of about 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subject 2 not analyzed as lost to follow up
Arm/Group Title Abilify Maintena
Hide Arm/Group Description:

Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.

Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: ng/ml
Baseline 49.2
5 months 14.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abilify Maintena
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter change in prolactin
Estimated Value 30
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abilify Maintena
Hide Arm/Group Description

Subjects will be switched to Abilify Maintena (Aripiprazole) LAI monthly doses of 400mg, 300mg, 200mg or 160mg and have their sexual functioning reevaluated over a 3 month period to determine if there is any significant sexual functioning improvement.

Abilify Maintena: For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period

All-Cause Mortality
Abilify Maintena
Affected / at Risk (%)
Total   0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abilify Maintena
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Psychiatric disorders   
hospitalization * [1]  1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
subject hospitalized and lost to follow up after an apparent overdose
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abilify Maintena
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Renal and urinary disorders   
urinary retention * [1]  1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
only adverse event reported was 2nd subject reported difficulty urinating at visit 5 then lost to follow up
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.
Results Point of Contact
Name/Title: Thomas D Gazda MD
Organization: Thomas D Gazda MD PC
Phone: 480 518 6299
Responsible Party: Gazda, Thomas D., M.D., PC
ClinicalTrials.gov Identifier: NCT02472652     History of Changes
Other Study ID Numbers: COL.AOM.2013-007
First Submitted: June 10, 2015
First Posted: June 16, 2015
Results First Submitted: August 22, 2018
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019