Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Investigaciones Médicas Montejo S.L.
ClinicalTrials.gov Identifier:
NCT00952757
First received: August 3, 2009
Last updated: August 5, 2009
Last verified: August 2009
  Purpose

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.


Condition
APS-related Hyperprolactinaemia
Schizophrenia
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-up

Resource links provided by NLM:


Further study details as provided by Investigaciones Médicas Montejo S.L.:

Primary Outcome Measures:
  • Variation in prolactin serum levels after switching to quetiapine [ Time Frame: From baseline to endpoint (month 6) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in the clinical symptoms related to hyperprolactinemia [ Time Frame: Baseline to endpoint (month 6) ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1.
Patients diagnosed of schizophrenia or bipolar disorder with APS-related hyperprolactinaemia who have been switched to quetiapine based on the clinician's judgement

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952757

Locations
Spain
Servicio de Psiquiatría
Avila, Spain, 05001
Servicio de Psiquiatria
Burgos, Spain, 09006
Hospital San Telmo
Palencia, Spain, 34004
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Servicio de Psiquiatria de Valladolid
Valladolid, Spain, 47001
Servicio de Psiquiatría
Zamora, Spain, 49007
Sponsors and Collaborators
Investigaciones Médicas Montejo S.L.
AstraZeneca
Investigators
Study Chair: Ángel L Montejo, Dr University of Salamanca
  More Information

No publications provided

Responsible Party: Dr. Angel Luis Montejo Gonzalez, University of Salamanca. Hospital Universitario Salamanca. Spain
ClinicalTrials.gov Identifier: NCT00952757     History of Changes
Other Study ID Numbers: D1443L00008, ANG-QUE-2006-1
Study First Received: August 3, 2009
Last Updated: August 5, 2009
Health Authority: Spain: Spanish Agency of Medicines
Spain: Consejería de Sanidad de la Junta de Castilla y León

Keywords provided by Investigaciones Médicas Montejo S.L.:
APS-related hyperprolactinaemia
Quetiapine
Schizophrenia
Bipolar

Additional relevant MeSH terms:
Bipolar Disorder
Hyperprolactinemia
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Quetiapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014