Aripiprazole, Abilify Maintena Collaborative Clinical Protocol
Condition: Sexual Dysfunction
Intervention: Abilify Maintena
Intervention description: 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
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          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
             antipsychotic treatment

          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
             severity.

          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.

        Exclusion Criteria:

          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
             suppressing menstruation

          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
             disorders.

          3. Has a CGI-S score at screening of grater than or equal to 5 (i.e. markedly ill or
             greater)

          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 -