What Would True Informed Consent for Antidepressants Actually Look Like?

June 30, 2025 – Psychiatric Drug Informed Consent Awareness Day

Today marks Psychiatric Drug Informed Consent Awareness Day. This is a time to reflect on what patients are (and aren’t) told before being prescribed antidepressants and other psychiatric drugs.

Let’s imagine, for a moment, a scenario in which a person sits in their doctor’s office and receives a true informed consent for an antidepressant prescription. One reflecting the full scope of the current scientific evidence.

It might go something like this:

Informed Consent Document: Antidepressant Treatment (e.g., SSRI/SNRI)

To be read and discussed with a qualified healthcare provider prior to initiating treatment.

1. Purpose of Medication

This medication is prescribed for the treatment of symptoms associated with the diagnostic labels of depression and/or anxiety. Antidepressants may reduce the intensity of emotional distress in some individuals in the short term, but they cannot solve the underlying cause of emotional suffering.

We call them “antidepressants”, but there’s nothing anti about them. These drugs to not specifically target depression. Rather, they produce broad, non-specific effects on mood, emotion, cognition, and physiology, which may or may not be experienced as helpful alternatives to distress.

2. Effectiveness

• Antidepressants have shown limited efficacy in industry-funded, biased, short-term clinical trials.

• In most studies, antidepressants do not significantly outperform a placebo.

• Response rates vary, and it is more common not to respond to the active ingredients in the drug than to respond. On average, approximately 15 out of 100 individuals will experience symptom relief beyond the placebo effect.

• The remaining patients may experience no improvement, worsening of symptoms, or improvements attributable to non-drug factors such as the placebo effect, natural remission, concurrent psychotherapy, social support, lifestyle changes, or the emotional validation that can come from receiving a diagnosis.

• Symptom relief may begin within 1–4 weeks, though full effects may take longer – probably because this improvement is often due to factors other than the medication itself, such as changes in life circumstances, therapeutic engagement, or increased support.
  

3. Long-Term Outcomes

• Continued use is often recommended in clinical practice, but evidence supporting long-term efficacy is lacking.

• Most randomized controlled trials of antidepressants last 6 to 12 weeks. Reliable data on long-term use (beyond one year) is limited, making the true long-term harms and benefits difficult to assess.

• While antidepressants may suppress and ease symptoms in the short-term, long-term use may paradoxically backfire. Some long-term studies – which are few and far between – have found that people who do not take medication for their depression generally experience fewer relapses over time compared with those who do.

• Long-term antidepressant use does not reliably protect against relapse. In one of the largest randomized trials of maintenance treatment, approximately 40% of patients relapsed within one year, despite continuing medication as prescribed.
  

4. Mechanism of action

• Antidepressants work by numbing or blunting your emotions.

• Like a painkiller that masks physical pain without treating its cause, antidepressants may reduce psychological pain without resolving its source. Their emotional effects can include both relief and flattening; like a sine wave that’s been squashed. Over time, your capacity for both positive and negative affect may diminish, including deep-felt joy, love, motivation, connection, or inner drive. These effects may interfere with relationships, decision-making, self-awareness, and therapeutic self-reflection.

• While it is commonly stated that depression is caused by a “chemical imbalance” (e.g., low serotonin), this theory is not supported by research. Antidepressants do not correct, rectify, or fix any known biological abnormality in your brain.

• The effect of taking this drug is not the same for everyone. For some, the drug may ease suffering. For others, it may cause paradoxical effects such as increased anxiety, agitation, intrusive thoughts, akathisia (intolerable inner restlessness), brain fog, or a further lowered mood.

• If you experience improvement while taking the drug, it may be helpful to reflect on the following:
  - How does the drug affect you emotionally, physically, and cognitively?
  - Which effects feel helpful?
  - Which feel unhelpful or limiting?
  - What is it that feels so relieving to not be in contact with? Which emotions inside you are the hardest to bear?
  - Are there any internal experiences – thoughts, emotions, feelings, urges, voices, memories – that feel so painful you’re trying to escape them?
  - Are there disadvantages to not feeling what is difficult to feel?

• If the medicated state provides relief, use that relief for something - don’t just remain in it passively. The temporary emotional calm may be a valuable opportunity to explore the deeper sources of your suffering; to explore what you’re depressed about. What is your depression or anxiety trying to tell you? What needs are unmet? What story lies underneath?
  

5. Adverse Effects

Antidepressants affect receptors and cells throughout the body, and so may cause a wide range of adverse effects. Side effects include:

• Nausea, headache, fatigue, weight gain, sexual dysfunction (e.g., loss of libido, difficulty achieving orgasm, and post-SSRI sexual dysfunction (PSSD) even following discontinuation), emotional numbing or blunting, indifference, apathy, insomnia, sedation, agitation, anxiety, restlessness, sweating, vertigo, dry mouth, increased suicidal thoughts, gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal discomfort), dizziness, light-headedness, memory problems, reduced concentration, brain fog, sleep disturbances (fragmented sleep, vivid dreams, or nightmares), visual disturbances, increased bleeding risk, mania or hypomania, among others.

• Adverse effects are often more pronounced during the initial phase of treatment, as the drug begins to take effect and accumulate in the body. As these early symptoms subside, it indicates that the body has adapted to the presence of the drug – potentially setting the stage for physiological dependence, withdrawal symptoms, and the need for gradual tapering upon discontinuation.
  

6. Risks and Adverse Effects of Long-Term Use

• Unknown.
  

7. Withdrawal Symptoms and Discontinuation

• Antidepressants – all antidepressants – can be difficult to come off.

• Withdrawal symptoms can range from mild or moderate discomfort to severely distressing or outright disabling. Symptoms can be severe, prolonged, and are often mistaken for relapse.

• If the drug is stopped abruptly or tapered too quickly, symptoms may persist for weeks, months, or even years.

• Many people find that their withdrawal symptoms are worse than the original condition.

• Incorrect tapering may mimic a return of the original condition, creating the false impression that the medication is still needed or that the individual wasn’t ready to stop – when in reality, the taper may simply have been too fast for the body to adapt, causing it to communicate via withdrawal symptoms.

• Withdrawal symptoms include:
  Insomnia, Sleep disturbance, Electric-shock sensations, Flu-like symptoms, Headache, Dizziness, Nausea, Irritability, Sweating, Gait instability, Unsteady gait, Imbalance, Fatigue, Vertigo, Parasthesias, Light-headedness, Tinnitus, Rushing/buzzing noise in head, Anorexia, Appetite disturbance, Loss of appetite, Lethargy, Chills, Vomiting, Anxiety, fear, Tachycardia, Vision disturbance, Blurred vision, Tremor, Ataxia, Nightmares, Diarrhea, Agitation, Abdominal pain/cramping, Numbness, Restlessness, Low mood, Emotional lability, Confusion, Dyspnea, Weakness, Tiredness, Drowsiness, Somnolence, Myalgias, Neuralgias, Altered taste, Pruritus, Myoclonus, Muscle rigidity, Jerkiness, Shaking, Muscle aches, Facial numbness, Flushing, Vivid dreams, Hypersomnia, Feeling tense, Panic/sudden panic, Depression, Suicidal ideation, Impulsiveness, Aggression/aggressive behavior, Anger/outbursts of anger, Bouts of crying, Mood swings, Derealization and depersonalization, Visual and auditory hallucinations, Disorientation, Decreased concentration, Amnesia, Genital hypersensitivity, Premature ejaculation, Convulsions, Arthralgias, Sore eyes, Restless legs, Tingling, Parkinsonism, Nervousness, Detachment, Slowed thinking, Delirium, Catatonia, Decreased liquid consumption, Pain, Infection, Malaise, Syncope, Palpitations, Hypertension, Stroke-like symptoms, Chest pain, Postural hypotension, Esophagitis, Feeling of abdominal distention, Increased bowel movements, Hyperesthesia, Hot and cold feelings, Burst of heat, Pricking sensations, Crawling sensations on the scalp, Spasm, Cramps, Coordination problems, Tonic clonic seizures, Slurred speech, Attention difficulties, Hypomania, Euphoria, Derealization, Dysphoria.

• Safely coming off after long-term use often requires gradual tapering over months or years, depending on individual sensitivity and duration of use, in order to allow the brain’s receptor systems to adapt slowly to the absence of the drug.

• Most prescribers are not trained in safe tapering methods.

• Most prescribers and healthcare professionals are unfamiliar with how to distinguish withdrawal symptoms from relapse.

• Standard available tablets are not designed for tapering. Most people will need to reduce the dose far below the lowest standard available tablet, which requires tablets to be split, cut, weighed, dissolved, or compounded to achieve small-enough reductions.
  

In short

If you choose to start an antidepressant, you deserve to know that:

• the drug may or may not help,

• if it helps, it likely means the drug has dampened or masked the symptoms of your underlying problem – which is likely still there,

• stopping the drug can be hard and may require a year-long, supported taper,

• long-term use may reduce your chance of full recovery,

• withdrawal symptoms may mimic or exceed the severity of the original condition,

• you have the right to decline treatment and explore alternative approaches.

Speak with your prescribing clinician or mental health professional if you have further questions or wish to discuss your treatment options in more detail. Be aware that, due to ongoing gaps between research and clinical practice, your prescriber may not be fully informed about the safety and efficacy of the drugs they provide. To access more comprehensive information about this drug, you can consult expensive, jargon-heavy, difficult-to-understand research articles in academic medical journals behind paywalls – or turn to layperson community networks, which often offer deeper and more up-to-date knowledge about these medications than many prescribers.

Acknowledgement

I have read or been read the information above and have had the opportunity to ask questions. I understand the potential benefits, harms, and alternatives associated with antidepressant treatment, including the limitations of long-term use and the potential challenges of stopping the drug again. I also understand that this medication was approved based on short-term clinical trials, and that the long-term effects remain largely unknown.

Patient Signature: ____________________ Date: __________
Clinician Signature: ___________________ Date: __________