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Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

NCT02472652 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-04-11

Study results available
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Summary

Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men and women. Antipsychotic induced sexual side effects may be a barrier to treatment compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have higher rates of causing prolactin elevations that may be implicated in sexual dysfunction. The basic premise of this study is to identify patients who believe they have experienced sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels. Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine if such a switch is helpful.

Conditions

  • Sexual Dysfunction

Interventions

DRUG

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

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Gazda, Thomas D., M.D., PC

    lead INDIV

Principal Investigators

  • Thomas D Gazda, MD · Private Practice

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2017-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472652 on ClinicalTrials.gov