Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole IM Depot
Intervention description: 400 mg intramuscular injection of aripiprazole
Intervention MeSH terms: Aripiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Safety; Tolerability; Schizophrenia; Aripiprazole

Summary:

      This study will test the safety of an aripiprazole injection in subjects with schizophrenia
      that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in
      this study will receive one injection of aripiprazole and will need to stop taking their
      other antipsychotic medication two weeks after the injection. The study will last one month.
      Subjects will be required to come to a clinic for evaluations and drug and urine collection
      five times during the course of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female individuals between 18 and 64 years of age, inclusive, with a
             diagnosis of schizophrenia as defined by DSM-IV-TR criteria.

          2. Good physical health as determined by no clinically significant deviation from normal
             in medical history, clinical laboratory determination, ECGs, or physical examinations.

          3. Ability to provide written informed consent or consent obtained from a legally
             acceptable representative (as required by IRB) prior to the initiation of any
             protocol-required procedures.

          4. Body mass index of 18 to 35 kg/m2, inclusive.

          5. Prior history of tolerating aripiprazole.

          6. Subjects must be treated with one of the following atypical oral antipsychotic
             medications: risperidone, olanzapine, quetiapine, ziprasidone, or paliperidone and be
             clinically stable, per the investigator's judgment, for 14 days prior to the
             administration of aripiprazole IM depot

        Exclusion Criteria:

          1. Sexually active males who will not commit to utilizing 2 of the approved birth control
             methods or who will not remain abstinent during the trial and for 180 days following
             the last dose of trial medication, or have not had an orchidectomy or sexually active
             females of childbearing potential who will not commit to utilizing 2 of the approved
             birth control methods or who will not remain abstinent during the trial and for 150
             days following the last dose of trial medication. Abstinence will be permitted if it
             is confirmed and documented at every trial visit. If employing birth control, 2 of the
             following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm,
             intrauterine device, birth control pill, birth control depot injections, implant,
             condom or sponge with spermicide. Note: Women of childbearing potential (WOCBP) are
             defined as all women unless they have had an oophorectomy or hysterectomy or have been
             postmenopausal for 12 consecutive months.

          2. Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the
             past 180 days; including alcohol and benzodiazepines, but excluding caffeine and
             nicotine. Subjects with a positive drug screen for cocaine or other drugs of abuse
             (excluding stimulants and other prescribed medications and marijuana).a

          3. Subjects likely to require prohibited concomitant therapy during the trial, and use of
             any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing
             and for the duration of the trial.

          4. Females who are pregnant or lactating.

          5. Subjects who had participated in any clinical trial involving a psychotropic
             medication within 1 month prior to enrollment; subjects who had participated in a
             previous IM depot trial within the last 6 months; or who had previously enrolled and
             received trial medication in an aripiprazole IM depot clinical trial.

          6. Any major surgery within 30 days prior to enrollment.

          7. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical, electrocardiographic, or clinical laboratory examinations.

          8. Subjects who have a significant risk of committing suicide based on history or routine
             psychiatric status examination

          9. Subjects currently in an acute relapse of schizophrenia.

         10. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including
             schizoaffective disorder, major depressive disorder, bipolar disorder, delirium,
             dementia, amnestic or other cognitive disorders. Also, subjects with borderline,
             paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.

         11. Subjects who were considered treatment-resistant to antipsychotic medication.
             (Subjects needed to have shown a previous response to an antipsychotic medication
             other than clozapine.)

         12. Subjects with a history of neuroleptic malignant syndrome or clinically significant
             tardive dyskinesia.

         13. Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
             with aripiprazole or other quinolinones.