APS-related HyperprolactinaemiaNCT00952757
Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine
An observational study of APS-related Hyperprolactinaemia and Schizophrenia, run by Investigaciones Médicas Montejo S.L. at 6 sites in Spain.
Trial summary
Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea, galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- APS-related Hyperprolactinaemia, Schizophrenia, Bipolar Disorder
- How many people
- 35 participants
- Where
- 6 sitesSpain
- Study dates
- Jun 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients diagnosed with schizophrenia or bipolar disorder who developed APS-related hyperprolactinaemia and were switched to quetiapine based on the clinician's judgement
Who may be able to join
- Informed consent signature.
- Men aged 18-50 years and women aged 18-45 years.
- Patients diagnosed of schizophrenia or bipolar disorder according to DSM-IV and on ambulatory psychiatric follow-up.
- Treated with one or more antipsychotics other than quetiapine for at least 8 weeks prior to inclusion in the study.
- Prolactin serum levels over 20 ug/L.
- That, in the opinion of the clinician, the origin of the hyperprolactinemia is the antipsychotic treatment administered previously to the patient.
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- Switching from previous antipsychotic treatment to quetiapine following the clinical criterion of the investigator in response to hyperprolactinemia in a period less than 5 days prior to inclusion in the study.
- Women with child-bearing potential using an effective contraceptive method and with a negative result in the pregnancy HCG test at the time of inclusion.
- Be able to understand and meet the study requirements.
Who cannot join
- Pregnant or nursing women.
- Mental retardation.
- Dependence or abuse of substances on inclusion according to DSM-IV criteria.
- Patients that, in the investigator's opinion, are at a high risk of suicide or mean a risk of aggression to others.
- Treated with any of the following drugs that can modify PRL levels on inclusion and during the study: antipsychotics, except for quetiapine, antidepressants -except for mirtazapine-, hormone therapy, spermicides, antiparkinson drugs or dopaminergic agonists, metoclopramide, domperidone, cimetidine or ranitidine, verapamil, enalapril, alpha-methyldopa, reserpine, morphine and other opioid derivatives, anti-retrovirals (protease inhibitors), vitamin D or any complex containing it. These drugs are excluded for their known potential effect on prolactin serum levels, sexual hormones and/or cortisol.
- Administration of an antipsychotic depot injection in one of the usual administration intervals of the depot (e.g., 3-4 weeks) prior to inclusion.
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- Be treated with any of the following P450-3A4 cytochrome inhibitors in the 14 days prior to inclusion, including: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, indinavir, nelfinavir, ritonavir and saquinavir.
- Be treated with any of the following P450-3A4 cytochrome inducers in the 14 days prior to inclusion, including: phenytoin, carbamazepine, barbiturates, rifampicin, St. John's wart, and glucocorticoids.
- Any contraindication to the use of quetiapine fumarate in the investigator's opinion (including lack of response to it in previous treatment attempts) (applies also to any other treatment to be used in the study -comparative agents-).
- Suffer any medical condition that can effect the absorption, distribution, metabolism or excretion of the study treatment(s).
- Suffer any medical condition in decompensation or not receiving inappropriate treatment for it in the investigator's opinion (e.g., diabetes, angina pectoris, hypertension...) and can affect psychotic symptoms and/or levels of prolactin, sexual hormones and/or cortisol.
- Suffering unstable diabetes.
- Absolute neutrophil count £1.5 x 109 per litre.
- Non-compliance with the study plan.
- Participation in a clinical trial in the four weeks prior to inclusion in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Servicio de Psiquiatría
Ávila, 05001
Servicio de Psiquiatria
Burgos, 09006
Hospital San Telmo
Palencia, 34004
Hospital Universitario de Salamanca
Salamanca, 37007
Servicio de Psiquiatria de Valladolid
Valladolid, 47001
Servicio de Psiquiatría
Zamora, 49007
About this study
Official title: Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-up
Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea, galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type and a potential increased risk of breast and prostate cancer.
Despite this growing evidence, there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient.
This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine (APS not related with the increase prolactin levels) in this problem.
Read the detailed description
Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia include most remarkably the appearance of amenorrhea, galactorrhea, tender breasts, and gynecomastia - associated with dysmorphophobia and psychological disorders in some cases, particularly in men-. Another common side effect is sexual dysfunction, with decreased libido, anorgasmia, and in men, impotence, reduced volume ejaculated and even backward ejaculation. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type. Furthermore, several authors have related hyperprolactinemic states with the development of breast cancer including a potential worse prognosis of it (Mandala, 1999; Clevenger 2003; Mujagic, 2004), and with the development of metastatic prostate cancer and resistance to hormone therapy in men (Lisonni, 2005)
Despite this growing evidence and the fact that APS with no apparent increase of prolactin levels exist, such as quetiapine or aripiprazole, many clinicians don't even monitor prolactin levels in patients following APS treatment. And when they do, they find there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient.
This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine in this problem.
- Keywords
- APS-related hyperprolactinaemia, Quetiapine, Schizophrenia, Bipolar
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. | Patients diagnosed of schizophrenia or bipolar disorder with APS-related hyperprolactinaemia who have been switched to quetiapine based on the clinician's judgement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in prolactin serum levels after switching to quetiapine
Measured: From baseline to endpoint (month 6)
Secondary outcomes (1)
Changes in the clinical symptoms related to hyperprolactinemia
Measured: Baseline to endpoint (month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APS-related HyperprolactinaemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigaciones Médicas Montejo S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Ángel L Montejo, Dr, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952757
- Sponsor's protocol ID
- D1443L00008
- Other IDs
- ANG-QUE-2006-1
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2009
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-up
- ClinicalTrials.gov ID
- NCT00952757
- Acronym / sponsor ID
- D1443L00008
- Keywords
- APS-related hyperprolactinaemia, Quetiapine, Schizophrenia, Bipolar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Investigaciones Médicas Montejo S.L.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea, galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type and a potential increased risk of breast and prostate cancer.
Despite this growing evidence, there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient.
This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine (APS not related with the increase prolactin levels) in this problem.
Detailed description
Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia include most remarkably the appearance of amenorrhea, galactorrhea, tender breasts, and gynecomastia - associated with dysmorphophobia and psychological disorders in some cases, particularly in men-. Another common side effect is sexual dysfunction, with decreased libido, anorgasmia, and in men, impotence, reduced volume ejaculated and even backward ejaculation. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type. Furthermore, several authors have related hyperprolactinemic states with the development of breast cancer including a potential worse prognosis of it (Mandala, 1999; Clevenger 2003; Mujagic, 2004), and with the development of metastatic prostate cancer and resistance to hormone therapy in men (Lisonni, 2005)
Despite this growing evidence and the fact that APS with no apparent increase of prolactin levels exist, such as quetiapine or aripiprazole, many clinicians don't even monitor prolactin levels in patients following APS treatment. And when they do, they find there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient.
This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine in this problem.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | – | –Patients diagnosed of schizophrenia or bipolar disorder with APS-related hyperprolactinaemia who have been switched to quetiapine based on the clinician's judgement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients diagnosed with schizophrenia or bipolar disorder who developed APS-related hyperprolactinaemia and were switched to quetiapine based on the clinician's judgement
Key inclusion criteria (9 listed)
- Informed consent signature.
- Men aged 18-50 years and women aged 18-45 years.
- Patients diagnosed of schizophrenia or bipolar disorder according to DSM-IV and on ambulatory psychiatric follow-up.
- Treated with one or more antipsychotics other than quetiapine for at least 8 weeks prior to inclusion in the study.
- Prolactin serum levels over 20 ug/L.
Key exclusion criteria (15 listed)
- Pregnant or nursing women.
- Mental retardation.
- Dependence or abuse of substances on inclusion according to DSM-IV criteria.
- Patients that, in the investigator's opinion, are at a high risk of suicide or mean a risk of aggression to others.
- Treated with any of the following drugs that can modify PRL levels on inclusion and during the study: antipsychotics, except for quetiapine, antidepressants -except for mirtazapine-, hormone therapy, spermicides, antiparkinson drugs or dopaminergic agonists, metoclopramide, domperidone, cimetidine or ranitidine, verapamil, enalapril, alpha-methyldopa, reserpine, morphine and other opioid derivatives, anti-retrovirals (protease inhibitors), vitamin D or any complex containing it. These drugs are excluded for their known potential effect on prolactin serum levels, sexual hormones and/or cortisol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation in prolactin serum levels after switching to quetiapine
Time frame: From baseline to endpoint (month 6)
1 secondary outcome
Changes in the clinical symptoms related to hyperprolactinemia
Time frame: Baseline to endpoint (month 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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.
Ángel L Montejo, Dr study chair
University of Salamanca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of APS-related Hyperprolactinaemia and Schizophrenia, run by Investigaciones Médicas Montejo S.L. at 6 sites in Spain.
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 15 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: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation in prolactin serum levels after switching to quetiapine (time frame: From baseline to endpoint (month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2009.