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GLOSSARY

What are some common terms associated with depression?

The following glossary contains medical definitions to help you understand terms related to the treatment of depression.

Adverse reactions

Any undesired actions or effects of a drug or treatment. Adverse reactions are also known as side effects. They are recorded as the percentage of patients who experience them; for example, if 10 people out of 100 in a clinical trial take a medicine and develop a headache, then 10% of the study participants experienced this adverse reaction.

Antidepressants

Medications that treat depression. There are several different types of antidepressants, such as selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors. They vary in how they work, in their side effects, and how they may interact with other medications.

Clinical trial

A research study designed to answer specific questions about new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective.

Contraindication

A situation in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.

Controlled study

A trial in which a test treatment is compared with a treatment that has known effects. While one treatment group receives the medication being studied, another group, called the control group, receives either no treatment, standard treatment (which may be another medicine or another approach to care), or placebo (sugar pill) in order to compare the effects of different treatments.

Diagnostic and Statistical Manual of Mental Disorders (DSM)

The standard classification reference for mental disorders used by mental health professionals in the United States.

Food and Drug Administration (FDA)

The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices.

Major depressive disorder (MDD)

A serious medical condition that is characterized by a combination of symptoms, including persistent sad, anxious, or "empty" moods; feelings of hopelessness, guilt, or worthlessness; helplessness and loss of interest or pleasure in activities that were once enjoyed. Symptoms of depression interfere with normal functioning and are not associated with other psychiatric conditions, including mixed, manic, or hypomanic episodes.

Major depressive episode

A person with depression has at least 5 of the following symptoms:

  • Depressed mood
  • Loss of interest or pleasure
  • Feelings of worthlessness or guilt
  • Agitation or restlessness
  • Fatigue or loss of energy
  • Trouble thinking, making decisions, or concentrating
  • Disturbed sleep, such as insomnia
  • Changes in appetite or weight
  • Thoughts of death or suicide or suicide attempts

At least one of the symptoms must be "depressed mood" or "loss of interest or pleasure." A person with depression will have experienced these symptoms for at least a 2-week period, and the symptoms will be noticeably different from what the patient experienced in the past.

Montgomery-Asberg Depression Rating Scale (MADRS)

A rating scale used by researchers to assess the severity of depression among diagnosed patients. It is designed to be sensitive to change resulting from treatment.

Neurotransmitter

A chemical in the brain that transmits nerve impulses from one neuron to an adjacent neuron at a place called a synapse.

Norepinephrine

A neurotransmitter and a hormone that aids in the regulation of cognition, motivation, and intellect.

Placebo

A biologically inactive substance administered to some participants in a clinical trial for the purpose of comparing no treatment to active treatment. In a blinded trial, patients do not know whether they are receiving a placebo or the drug being tested.

Psychiatrist

A physician who specializes in the diagnosis and treatment of mental illnesses.

Psychiatry

The medical specialty concerned with the diagnosis and treatment of mental illnesses.

Psychologist

A person trained in the study of the mind and behavior in relation to different areas of human activity, including the family, education, and employment and also trained in the treatment of mental health problems.

Psychotherapist

A professionally trained and licensed person who uses a variety of techniques to improve the mental health and coping skills of their patients. Psychotherapists come from diverse backgrounds and include psychologists, counselors, social workers, and psychiatrists.

Psychotherapy

Treatment of emotional, behavioral, personality, and psychiatric disorders in the context of an established therapeutic relationship between a psychotherapist and client/group. Most forms of psychotherapy use verbal communication; interpersonal and cognitive-behavioral therapies are among the most common.

Selective serotonin reuptake inhibitor (SSRI)

A class of antidepressants used to treat major depressive disorder. SSRIs are thought to work by inhibiting the reuptake of serotonin, an action which allows more serotonin to be available to be taken up by other nerves.

Serotonin and norepinephrine reuptake inhibitor (SNRI)

A class of antidepressants used to treat major depressive disorder. SNRIs are thought to work by inhibiting the reuptake of serotonin and norepinephrine.

Serotonin

A neurotransmitter that aids in the regulation of mood, appetite, sleep, muscle contraction, and some brain functions, including memory and learning.

Sheehan Disability Scale (SDS)

A self-rated scale, designed to measure the extent to which a patient’s functioning is impaired by depressive symptoms in three major categories: work/school life, social life, and family/home life.

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FETZIMA INDICATION AND USAGE

FETZIMA (levomilnacipran) extended-release capsules is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.

It is not known if FETZIMA is safe and effective for use in children.

FETZIMA is not for use for the management of fibromyalgia, and its efficacy and safety have not been established for that use.

IMPORTANT RISK INFORMATION

FETZIMA may cause serious side effects, including:

Increased risk of suicidal thoughts or actions in some children, adolescents, and young adults. FETZIMA and other antidepressant medicines may increase suicidal thoughts or actions in some children and young adults, especially within the first few months of treatment or when the dose is changed. FETZIMA is not for use in children.

Call your healthcare provider or get emergency medical help right away if you or your family member have any of these symptoms, especially if they are new, worse, or worry you:

FETZIMA may cause serious side effects, including:

DO NOT take FETZIMA if you:

Do not start taking an MAOI for at least 7 days after you stop treatment with FETZIMA.

Before taking FETZIMA, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:

Do not start or stop any other medicines during treatment with FETZIMA without talking to your healthcare provider first. Stopping FETZIMA suddenly may cause you to have serious side effects

Avoid drinking alcohol during treatment with FETZIMA Do not drive, operate heavy machinery, or do other dangerous activities until you know how FETZIMA affects you. FETZIMA can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

The most common side effects of FETZIMA include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FETZIMA. For more information, ask your healthcare provider or pharmacist.

IMPORTANT RISK INFORMATION

More

FETZIMA INDICATION AND USAGE

FETZIMA (levomilnacipran) extended-release capsules is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.

It is not known if FETZIMA is safe and effective for use in children.

FETZIMA is not for use for the management of fibromyalgia, and its efficacy and safety have not been established for that use.

IMPORTANT RISK INFORMATION

FETZIMA may cause serious side effects, including:

Increased risk of suicidal thoughts or actions in some children, adolescents, and young adults. FETZIMA and other antidepressant medicines may increase suicidal thoughts or actions in some children and young adults, especially within the first few months of treatment or when the dose is changed. FETZIMA is not for use in children.

  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness) or have a history of suicidal thoughts or actions.
  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency medical help right away if you or your family member have any of these symptoms, especially if they are new, worse, or worry you:
  • Attempts to commit suicide; acting on dangerous impulses; acting aggressive; being angry or violent; thoughts about suicide or dying; new or worsening depression or anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worsening irritability; an extreme increase in activity or talking (mania); or other unusual changes in behavior or mood

FETZIMA may cause serious side effects, including:

  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when FETZIMA is taken with certain other medicines. Stop taking FETZIMA and call you healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
    • agitation, confusion, fast heart beat, dizziness, flushing, tremors, stiff muscles or muscle twitching, seizures, seeing or hearing things that are not real (hallucinations), coma, blood pressure changes, sweating, high body temperature (hyperthermia), loss of coordination, nausea, vomiting, or diarrhea.
  • High blood pressure (hypertension). Your healthcare provider should check your blood pressure before you start and during treatment with FETZIMA. If you have high blood pressure, it should be controlled before you start treatment with FETZIMA.
  • Increased heart rate. Your healthcare provider should check your heart rate before you start and during treatment with FETZIMA. If you have heart problems or problems with an abnormal heartbeat, your problems should be treated before you start treatment with FETZIMA.
  • Increased risk of bleeding: Taking FETZIMA with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
  • Eye problems (angle-closure glaucoma): Many antidepressant medicines, including FETZIMA, may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.
  • Problems with urination: FETZIMA may cause you to have problems with urination including decreased urine flow and being unable to pass any urine. Tell your healthcare provider if you develop any problems with urine flow during treatment with FETZIMA.
  • Manic episodes. Manic episodes may happen in people with bipolar disorder who take FETZIMA. Symptoms may include: greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster than usual, severe trouble sleeping, reckless behavior, excessive happiness or irritability.
  • Seizures (convulsions)
  • Discontinuation symptoms: Suddenly stopping FETZIMA may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include: changes in your mood, irritability and agitation, dizziness, electric shock sensation (paresthesia), anxiety, confusion, headache, tiredness, problems sleeping, hypomania, ringing in your ears (tinnitus) and seizures.
  • Low sodium levels in the blood (hyponatremia): Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Symptoms may include headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet. In severe or more sudden cases, signs and symptoms include: hallucinations (seeing or hearing things that are not real), fainting, seizures, coma, respiratory arrest, and death.

DO NOT take FETZIMA if you:

  • are allergic to levomilnacipran, milnacipran HCl, or any of the ingredients in FETZIMA
  • take a monoamine oxidase inhibitor (MAOI)
  • have stopped taking an MAOI within the last 14 days
  • are being treated with the antibiotic linezolid or intravenous methylene blue

Do not start taking an MAOI for at least 7 days after you stop treatment with FETZIMA.

Before taking FETZIMA, tell your healthcare provider if you:

  • have or have a family history of suicide, depression, bipolar disorder, mania, or hypomania
  • have high blood pressure
  • have or had heart problems or stroke
  • have or had bleeding problems
  • have glaucoma (high pressure in the eye)
  • have or had problems urinating (hesitating) or emptying your bladder (retention)
  • have or had seizures (convulsions)
  • have low sodium levels in your blood
  • have or had kidney problems
  • drink alcohol
  • are pregnant or plan to become pregnant. FETZIMA may harm your unborn baby. Taking FETZIMA during your third trimester of pregnancy may cause an increased risk of bleeding after delivery and may cause harm to your baby. Talk to your healthcare provider about the risks to you and your baby if you take FETZIMA during pregnancy.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with FETZIMA.
    • There is a pregnancy registry for females who are exposed to FETZIMA during pregnancy. The purpose of the registry is to collect information about the health of females exposed to FETZIMA and their baby. If you become pregnant during treatment with FETZIMA, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
  • are breastfeeding or plan to breastfeed. It is not known if FETZIMA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with FETZIMA.
    • If you breastfeed during treatment with FETZIMA, call you healthcare provider right away if your baby develops sleepiness or fussiness, or is not feeding or gaining weight well.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • FETZIMA and other medicines may affect each other causing possible serious side effects.
  • FETZIMA may affect the way other medicines work and other medicines may affect the way FETZIMA works.
Especially tell your healthcare provider if you take:
  • medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), MAOIs, medicines used to treat migraine headache known as triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, or St. John’s Wort.
  • medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin
  • diuretics

Do not start or stop any other medicines during treatment with FETZIMA without talking to your healthcare provider first. Stopping FETZIMA suddenly may cause you to have serious side effects

Avoid drinking alcohol during treatment with FETZIMA Do not drive, operate heavy machinery, or do other dangerous activities until you know how FETZIMA affects you. FETZIMA can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

The most common side effects of FETZIMA include:

  • Nausea, vomiting, constipation, sweating, abnormal heart beat, and erectile dysfunction.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FETZIMA. For more information, ask your healthcare provider or pharmacist.