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Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine: a Naturalistic, Prospective, Multicentric Observational Study of 6 Months Follow-up

18 Years
50 Years
Not Enrolling
APS-related Hyperprolactinaemia, Schizophrenia, Bipolar Disorder

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Trial Information

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 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.

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Variation in prolactin serum levels after switching to quetiapine

Outcome Time Frame:

From baseline to endpoint (month 6)

Safety Issue:


Principal Investigator

Ángel L Montejo, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

University of Salamanca


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2007

Completion Date:

August 2008

Related Keywords:

  • APS-related Hyperprolactinaemia
  • Schizophrenia
  • Bipolar Disorder
  • APS-related hyperprolactinaemia
  • Quetiapine
  • Schizophrenia
  • Bipolar
  • Bipolar Disorder
  • Hyperprolactinemia
  • Schizophrenia