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.
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
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
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.
1. Are able to provide written informed consent
2. Have a primary diagnosis of schizophrenia as determined by DSM-IV or DSM-V criteria.
3. Have a history of schizophrenia for greater than or equal to 2 years prior to
screening documented from a reliable source (e.g. healthcare provider or medical
records), and a history of symptom exacerbation or relapse when not receiving
4. Are currently taking Invega Sustenna or Risperdal Consta
5. Have sexual dysfunction as defined by a score of greater than or equal to 19 on the
ASEX or a score of greater than or equal to 5 on any one of item or a score of
greater than or equal to 4 on any of each of three items (total score greater than or
equal to 12 on the three items)
6. Experienced sexual dysfunction while treated with Invega Sustenna or Risperdal Consta
7. Have a minimal baseline sexual activity as defined as an ASEX score recalled from
prior to initiation of Invega Sustenna or Risperdal Consta that is at least 2 points
less than the total score at screening and not greater than or equal to 25 in
8. Are able to understand the nature of the study and follow protocol requirements,
including the prescribed dosage regimens, IM depot injection, discontinuation of
prohibited concomitant medications, read and understand the written word in order to
complete subject-reported outcome measures (including sexual functioning), and be
reliably rated on assessment scales
9. Are male or female subjects who are surgically sterile or willing to employ a form of
birth control including vaginal diaphragm, intrauterine device, birth control pill,
birth control implant, birth control once monthly injections, condom or vaginal
sponge with spermicide.
1. Are female with amenorrhea for 3 consecutive months prior to screening, with the
exception of women who are on Depo-Provera or oral contraceptives for the purpose of
2. Has a current DSM-IV or DSM-V diagnosis other that schizophrenia including
schizophreniform disorder, schizoaffective disorder, major depressive disorder,
bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also
excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid,
antisocial personality disorder, or any Axis II disorders or confounding Axis I
3. Has a CGI-S score at screening of grater than or equal to 5 (i.e. markedly ill or
4. Has a diagnosis of type I or Type II diabetes unless diet controlled
5. Uses more than once daily antihypertensive medication, or greater than once per day
dosing is allowed if on monotherapy (e.g. angiotensin-converting-enzyme inhibitors,
angiotensin II receptor blockers, alpha blockers, and calcium channel blockers) with
the exception of beta blockers and diuretics which are only allowed if once per day.
6. Is considered resistant or refractory to antipsychotic treatment by history (failed
two prior antipsychotic medication studies) or response only to clozapine -