Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

NCT02472652 | Terminated Phase 4 Results

• 1 other identifier: COL.AOM.2013-007
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Arizona Sexual Experiences Scale (ASEX) Score

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)

  Baseline and Endpoint average of about 5 months

Study Arms (1)

Abilify Maintena

OTHER

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

Interventions

Abilify Maintena DRUG

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

Also known as: Aripiprazole

Abilify Maintena

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Are able to provide written informed consent
• Have a primary diagnosis of schizophrenia as determined by DSM-IV or DSM-V criteria.
• 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
• Are currently taking Invega Sustenna or Risperdal Consta
• 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)
• Experienced sexual dysfunction while treated with Invega Sustenna or Risperdal Consta
• 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.
• 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
• 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.

You may not qualify if:

• 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
• 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.
• Has a CGI-S score at screening of grater than or equal to 5 (i.e. markedly ill or greater)
• Has a diagnosis of type I or Type II diabetes unless diet controlled
• 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.
• Is considered resistant or refractory to antipsychotic treatment by history (failed two prior antipsychotic medication studies) or response only to clozapine -

Sponsors & Collaborators

• Gazda, Thomas D., M.D., PC: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

Mohammed Ramadan MD Private Practice

Bullhead City, Arizona, 86442, United States

Location

Related Publications (4)

• Baggaley M. Sexual dysfunction in schizophrenia: focus on recent evidence. Hum Psychopharmacol. 2008 Apr;23(3):201-9. doi: 10.1002/hup.924.

  PMID: 18338766 BACKGROUND

• Henderson DC, Doraiswamy PM. Prolactin-related and metabolic adverse effects of atypical antipsychotic agents. J Clin Psychiatry. 2008;69 Suppl 1:32-44.

  PMID: 18484806 BACKGROUND

• Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.

  PMID: 19102734 BACKGROUND

• de Boer MK, Wiersma D, Bous J, Sytema S, van der Moolen AE, Wilffert B, Hamamura T, Knegtering H. A randomized open-label comparison of the impact of aripiprazole versus risperidone on sexual functioning (RAS study). J Clin Psychopharmacol. 2011 Aug;31(4):523-5. doi: 10.1097/JCP.0b013e318222bb29. No abstract available.

  PMID: 21720224 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Thomas D Gazda MD
• Organization: Thomas D Gazda MD PC

goodgazda@yahoo.com

480 518 6299

Study Officials

• Thomas D Gazda, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: March 1, 2017
• Last Updated: April 11, 2019
• Results First Posted: April 11, 2019

Record last verified: 2019-03

Locations

US (1)