Sexual DysfunctionPhase 4KISSNCT02472652
Aripiprazole, Abilify Maintena Collaborative Clinical Protocol
A Phase 4 study testing Abilify Maintena in people with Sexual Dysfunction, run by Gazda, Thomas D., M.D., PC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Abilify Maintena
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Mar 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Mohammed Ramadan MD Private Practice
Bullhead City, Arizona, 86442
About this study
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
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.
Read the detailed description
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 schizophrenia.
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 study drug.
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.
- Conditions
- Sexual Dysfunction
- Being tested
- Abilify Maintena
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abilify MaintenaDrug
Also called Aripiprazole
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Abilify Maintena |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)
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
Measured: Baseline and Endpoint average of about 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion31 Dec 2016
- Study completion1 Mar 2017
Why it stopped: Lack of adequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazda, Thomas D., M.D., PC
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Thomas D Gazda, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472652
- Sponsor's protocol ID
- COL.AOM.2013-007
- Acronym
- KISS
- Status last verified
- Mar 2019
- First submitted
- 10 Jun 2015
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baggaley M. Sexual dysfunction in schizophrenia: focus on recent evidence. Hum Psychopharmacol. 2008 Apr;23(3):201-9. doi: 10.1002/hup.924.
PubMed 18338766Henderson DC, Doraiswamy PM. Prolactin-related and metabolic adverse effects of atypical antipsychotic agents. J Clin Psychiatry. 2008;69 Suppl 1:32-44.
PubMed 18484806Hanssens 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.
PubMed 19102734de 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.
PubMed 21720224
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02472652
- Acronym / sponsor ID
- KISS / COL.AOM.2013-007
- Conditions
- Sexual Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of adequate enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Gazda, Thomas D., M.D., PC
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jun 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Posted 11 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 schizophrenia.
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 study drug.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abilify Maintena | Other | Drug: Abilify MaintenaSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abilify MaintenaAlso: AripiprazoleFor 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 | Drug | Abilify Maintena |
Primary outcome
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.
1 secondary outcome
Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)
Time frame: Baseline and Endpoint average of about 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18338766Baggaley M. Sexual dysfunction in schizophrenia: focus on recent evidence. Hum Psychopharmacol. 2008 Apr;23(3):201-9. doi: 10.1002/hup.924.
- Background: PubMed 18484806Henderson DC, Doraiswamy PM. Prolactin-related and metabolic adverse effects of atypical antipsychotic agents. J Clin Psychiatry. 2008;69 Suppl 1:32-44.
- Background: PubMed 19102734Hanssens 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.
- Results publication: PubMed 21720224de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Gazda, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abilify Maintena in people with Sexual Dysfunction, run by Gazda, Thomas D., M.D., PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arizona Sexual Experiences Scale (ASEX) Score (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472652, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.