A Study of Prolactin Levels in Women with Chronic Migraine

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-006778
    Sponsor Protocol Number: 16-006778

About this study

The purpose of this study is to identify whether there is a difference in prolactin levels between patients with chronic migraine and healthy controls. This may help to explain the sensitivity to pain those patients with chronic migraine experience and may also help to establish a target for new treatments of chronic migraine

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Cases
    • Female
    • Age 18-50 years
    • Diagnosis of chronic migraine as defined by the ICHD III beta criteria
    • Must self-report a typically regular menstrual cycle
  • Controls
    • Female
    • Healthy 
    • Age 18-50 years
    • Must self-report a typically regular menstrual cycle

Exclusion Criteria

  • Cases
    • Has significantly elevated anxiety and depression inventory scores (GAD-7 score of 10 or higher and PHQ-9 score of 10 or higher)
    • Self-reports an unreliable menstrual cycle
    • A history of a pituitary adenoma or history of spontaneous galactorrhea
    • Has known hyperprolactinemia
    • Currently taking medications which can affect serum prolactin levels (drugs are listed below)
    • Pregnant or breastfeeding
    • History of schizophrenia or psychosis
  • Controls
    • Has significantly elevated anxiety and depression inventory scores (GAD-7 score of 10 or higher and PHQ-9 score of 10 or higher)
    • Of reproductive age with menstrual cycles  impossible to predict
    • A history of pituitary adenoma or history of spontaneous galactorrhea
    • Has known hyperprolactinemia
    • Currently taking any drugs which can affect serum prolactin levels (drugs are listed below)
    • Pregnant or breastfeeding
    • History of schizophrenia or psychosis
  • Drugs that affect prolactin levels that will exclude both cases and controls
    • Chlorpromazine
    • Fluphenazine
    • Haloperidol
    • Loxapine 
    • Perphenazine
    • Pimozide
    • Thiothixene
    • Trifluoperazine
    • Aripiprazole
    • Asenapine
    • Clozapine
    • Ilperidone
    • Lurasidone
    • Olanzepine
    • Paliperidone
    • Quetiapine
    • Risperidone
    • Ziprasidone
    • Amitriptyline
    • Desipramine
    • Clomipramine
    • Metoclopramide 
    • Domperidone
    • Prochrlorperazine
    • Verapamil
    • Methyldopa
    • Methadone
    • Morphine
    • Hydropmorphone
    • Oxydocone
    • Hydrocodone
    • Codeine

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amaal Starling, M.D.

Open for enrollment

Contact information:

William Kingston M.D.

Kingston.William@mayo.edu

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CLS-20268655

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