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Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (KISS)

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ClinicalTrials.gov Identifier: NCT02472652
Recruitment Status : Terminated (Lack of adequate enrollment)
First Posted : June 16, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Gazda, Thomas D., M.D., PC

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Drug: Abilify Maintena Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Determine the Effect of Switching to Aripiprazole Once Monthly for Subjects With Schizophrenia Experiencing Worsening Sexual Dysfunction With Invega Sustenna or Risperdal Consta
Study Start Date : June 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Abilify Maintena
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.
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
Other Name: Aripiprazole

Primary Outcome Measures :
  1. Change in Arizona Sexual Experiences Scale (ASEX) Score [ Time Frame: Baseline and 12 weeks ]
    Subjects enrolled in this study will be followed for an average of about 5 months. The ASEX will be done at screening to ensure subjects meet criteria for sexual dysfunction as defined by the scale. In addition subjects must remember at least a 2 point change in the scale since starting Invega Sustenna or Risperdal Consta. Subjects must also score no greater than or equal to 25 on the scale to ensure a baseline of minimal sexual activity. The primary outcome of the study is the change in ASEX score from Baseline to Endpoint. Total scores range from 5 - 30 with the higher scores indicating more sexual dysfunction.

Secondary Outcome Measures :
  1. Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml) [ Time Frame: Baseline and Endpoint average of about 5 months ]
    Subjects enrolled in this study will be followed for an average of about 5 months. Serum prolactin concentrations will be measured to assess change from Baseline to Endpoint

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472652

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United States, Arizona
Mohammed Ramadan MD Private Practice
Bullhead City, Arizona, United States, 86442
Sponsors and Collaborators
Gazda, Thomas D., M.D., PC
Otsuka America Pharmaceutical
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Principal Investigator: Thomas D Gazda, MD Private Practice
Publications of Results:
Other Publications:
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Responsible Party: Gazda, Thomas D., M.D., PC
ClinicalTrials.gov Identifier: NCT02472652    
Other Study ID Numbers: COL.AOM.2013-007
First Posted: June 16, 2015    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists