Postnatal depression

Last reviewed:November 2019

Last updated:July 2019

11 Jul 2019

US FDA approves brexanolone, the first drug approved specifically to treat postpartum depression

The US Food and Drug Administration (FDA) has approved brexanolone - the first-ever approval of a drug specifically to treat postnatal depression.
Brexanolone is a synthetic version of the natural neurosteroid allopregnanolone, and binds to gamma-aminobutyric acid (GABA) type A receptors. Brexanolone is given by continuous intravenous infusion over a total of 60 hours (2.5 days).
The efficacy of brexanolone was evaluated in one phase 2 and two phase 3 trials in women with severe or moderate postnatal depression. In all three studies, women treated with brexanolone showed a greater improvement in depressive symptoms from baseline (using the Hamilton Rating Scale for Depression) than controls at the end of the first infusion (60 hours).[88][89] The phase 2 trial also showed a statistically significant benefit at 30 days.[88]
The most common side effects in the brexanolone groups were headache, dizziness, and somnolence.
Because of concerns about potential serious risks during infusion, including excessive sedation or sudden loss of consciousness, brexanolone is only available through a Risk Evaluation and Mitigation Strategy (REMS) at certified medical facilities. Women having the infusion must be monitored continuously, and be accompanied during any interactions with their children.
The place of brexanolone in the treatment of postnatal depression is still considered emerging by most experts. It is not yet available in Europe or the UK. In November 2016, the European Medicines Agency granted brexanolone a PRIME status, a scheme which recognises it as a priority medicine, where development plans are optimised and evaluation may be accelerated.

Summary

Refers to the development of a depressive illness following childbirth and may form part of a unipolar or, less frequently, a bipolar illness.

Aetiology is poorly understood but is likely to involve an interaction between psychological, social, and biological factors.

Women may present with a history of depressed mood, anhedonia, weight changes, sleep disturbance, psychomotor problems, low energy, excessive guilt, loss of confidence or self-esteem, poor concentration, or suicidal ideation.

The presence of a bipolar disorder must be excluded in all patients.

Treatment is with psychological therapy and/or medication. Antidepressants are recommended for more severe episodes if the woman declines psychological therapy or if psychological therapy is either ineffective or unavailable.

Psychiatric referral may be necessary for patients who do not respond to treatment. Urgent psychiatric assessment is warranted if there is a risk of self-harm or harm to the child at any time, or if a postnatal psychosis, or manic or mixed episode, is suspected.

Episodes of postnatal depression last 3 to 6 months on average, but a few women remain depressed at 1 year.

Definition

Postnatal depression refers to the development of a depressive illness following childbirth and may form part of a bipolar or, more usually, a unipolar illness.[1] Postnatal depression is not recognised by current classification systems as a condition in its own right, but the onset of a depressive episode within 4 weeks of childbirth can be recorded via the perinatal-onset specifier in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5).[2] There is evidence to suggest that the DSM-5 specifier is too narrow.[3] Hence, in common usage, depressive episodes occurring within 6 to 12 months of delivery may be considered to be postnatal depression.

History and exam

Key diagnostic factors

presence of risk factors
depressed mood
anhedonia
decreased energy or increased fatigability
suicidal ideation
loss of confidence or self-esteem
unreasonable feelings of self-reproach or excessive and inappropriate guilt
poor concentration

Full details

Other diagnostic factors

change in psychomotor activity
sleep disturbance
change in appetite
change in weight
obsessive thoughts
significant self-harm or neglect or mistreatment of children
personal or family history of hypomania or mania
psychotic symptoms

Full details

Risk factors

history of depressed mood, depression, or anxiety
recent stressful life events
poor social support
discontinuation of psychopharmacological treatments
sleep deprivation
postnatal hypomania
personality disorder
birth complications
poor socioeconomic status
age less than 16 years
familial and genetic factors
violence by partner during pregnancy

Full details

Diagnostic investigations

1st investigations to order

Depression identification questions

Full details

Investigations to consider

Edinburgh Postnatal Depression Scale
Mood Disorder Questionnaire (MDQ)
Thyroid function tests
FBC
urine drug screen
brain CT or MRI

Full details

Treatment algorithm

ACUTE

unipolar depression

bipolar depression

Contributors

AuthorsVIEW ALL

Arianna Di Florio, MD, PhD

Clinical Senior Lecturer

MRC Centre for Neuropsychiatric Genetics and Genomics

Cardiff University

Cardiff

Disclosures

ADF is an author of references cited in this topic.

Ian Jones, MB BS, MRCPsych, PhD

Professor of Psychiatry

MRC Centre for Neuropsychiatric Genetics and Genomics

Cardiff University

Cardiff

Disclosures

IJ has received honorariums or consultancy fees from Lilly, GlaxoSmithKline, Lundbeck, Sanofi-Aventis, Janssen-Cilag, and AstraZeneca, and has received research funding from GlaxoSmithKline. IJ is also an author of references cited in this topic.

Peer reviewersVIEW ALL

Margaret Spinelli, MD

Associate Professor of Psychiatry

Columbia University

New York

Disclosures

MS declares that she has no competing interests.

Anne-Laure Sutter, MD, PhD

Head of the Perinatal Psychiatry Network

University Department of Adult Psychiatry

CH Charles Perrens

Bordeaux

France

Disclosures

ALS declares that she has no competing interests.

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US FDA approves brexanolone, the first drug approved specifically to treat postpartum depression

Summary

Definition

History and exam

Key diagnostic factors

Other diagnostic factors

Risk factors

Diagnostic investigations

1st investigations to order

Investigations to consider

Treatment algorithm

unipolar depression

bipolar depression

Contributors

AuthorsVIEW ALL

Arianna Di Florio, MD, PhD

Disclosures

Ian Jones, MB BS, MRCPsych, PhD

Disclosures

Peer reviewersVIEW ALL

Margaret Spinelli, MD

Disclosures

Anne-Laure Sutter, MD, PhD

Disclosures

Differentials

Guidelines

Patient leaflets

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