Trial Outcomes & Findings for Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (NCT NCT02472652)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Abilify Maintena 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 Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Abilify Maintena 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 Study Lost to Follow-up	1

Baseline Characteristics

Second subject lost to follow up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abilify Maintena n=2 Participants 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
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants
Region of Enrollment United States	2 participants n=2 Participants
ASEX (Arizona Sexual Experiences Scale)	11 units on a scale n=1 Participants • Second subject lost to follow up

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Data no available for Subject 2 as lost to follow up

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.

Outcome measures

Outcome measures
Measure	Abilify Maintena n=1 Participants 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
Change in Arizona Sexual Experiences Scale (ASEX) Score	11 units on a scale

SECONDARY outcome

Timeframe: Baseline and Endpoint average of about 5 months

Population: Subject 2 not analyzed as lost to follow up

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

Outcome measures

Outcome measures
Measure	Abilify Maintena n=1 Participants 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
Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml) Baseline	49.2 ng/ml
Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml) 5 months	14.2 ng/ml

Adverse Events

Abilify Maintena

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abilify Maintena n=2 participants at risk 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
Psychiatric disorders hospitalization	50.0% 1/2 • Number of events 1

Other adverse events

Other adverse events
Measure	Abilify Maintena n=2 participants at risk 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
Renal and urinary disorders urinary retention	50.0% 1/2 • Number of events 1

Additional Information

Thomas D Gazda MD

Thomas D Gazda MD PC

Phone: 480 518 6299

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place