Clinical trial NCT02472652
Conditions: Sexual Dysfunction
Sponsor: Gazda, Thomas D., M.D., PC
Start date: 2015-06-01; Completion date: 2017-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
The study will be performed at several sites and oversight of the study is being monitored by Thomas D Gazda MD PC in accordance with established research principals, the ICH GCP (International Conference on Harmonization Good Clinical Practice) Guideline, FDA regulations and applicable regulatory requirements and local laws.

Source documents will be used to help ensure that patients meet diagnostic criteria for schizophrenia.

All AE (Adverse Event) verbatim descriptions will be performed (investigator terms from the CRF, Clinical Research File) will be classified into standardized medical terminology using the Medical Dictionary for Regulatory Activities (MedDRA).

Treatment emergent AEs (TEAEs) will be summarized. The incidence of TEAEs will be reported as the number (percentage) of subjects with TEAs by SOC (Standard of Care) and PT (Preferred Term). The number(percentage) of subjects with TEAEs will also be summarized by relationship to study drug (possibly related, probably related and not related).

Adverse events will be summarized using the Safety Analysis Sets. The number of AEs and number and incidence (%) of subjects with AEs will be summarized by cohort or dose and overall. For clinically significant events, tome of onset and recovery will be reported.

The number (percentage) of subjects with TEAEs leading to death will be summarized by MedDRA SOC and PT. A subject data listing of all AEs leading to death will be provided.

The number(percentage) of subjects with SAEs will be summarized by MedDRA SOC and PT.

The number (percentage) of subjects with TEAEs leading to discontinuation from study drug will be summarized by MedDRA SOC and PT. A subject data listing of all AEs leading to discontinuation from the study will be provided.

All safety analysis will be performed on the Safety Analysis Sets. Safety data will be summarized on an "as treated" basis using descriptive statistics (e.g. n, mean, standard deviation, median, minimum, maximum, for continuous variables: n(%) for categorical variables). Safety variables include TEAEs, clinical laboratory parameters, vital signs, SST). Study Day 1 for all safety analysis will be defined as the date of the first dose of study drug.

The primary analysis of the primary efficacy endpoint will be based on a one-sample two sided t-test. Missing values will be imputed using the last observation carried forward (LOCF). The ASEX at the end of the 3 months of treatment is considered to be lower than baseline if the 2-sided p-value of the one-sample t-test statistic is less than or equal to 0.05. As additional information, the two-sided 95% confidence interval for the change from baseline in ASEX score will be provided based on t-distribution at the end of the 3 months of aripiprazole once monthly treatment and at each scheduled visit.

As sensitivity analysis, the primary analysis will be repeated based on the observed data; also, a mixed effect analysis of covariance regression will be used to model the change from baseline in ASEX at scheduled visits. Baseline ASEX scores will be the fixed effect, subject will be the random effect, and scheduled visit will be the repeated factor in the model.

The key secondary analysis will be analyzed in the same way as the primary efficacy analysis

The study -conduct duration is approximately 4 months. Screening for subjects will last approximately 8 months for a total study duration of 12 months.

it is projected that a minimum of 22 subjects will be enrolled with an estimate that 19 subjects will complete the study.

Arms: arm 1: 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.
Interventions: intervention 1: Abilify Maintena
Intervention descriptions: intervention 1: 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

Protocol documents: