Informed Consent-fill in
HARMED Hearts
Doctor Informed Consent Worksheet — Antidepressant (Generic)
Part 1 — Basics (doctor completes)
- Diagnosis/indication:
- FDA-approved for this condition? ☐ Yes ☐ No (off-label)
- Starting dose + titration schedule:
Part 2 — FDA Black Box Warning (suicidality)
- I explained the FDA suicidality warning (higher risk up to age 24; risk when starting/changing doses). Doctor initials:
- I advised family/loved ones on red flags to monitor and when to seek help. Doctor initials:
Part 3 — Half-Life & Withdrawal
- I explained this drug’s half-life (___ hours) and how missed/late doses may trigger withdrawal. Doctor initials:
- We discussed a slow, individualized taper; abrupt stopping is unsafe. Doctor initials:
Part 4 — Receptor Occupancy (pharmacology)
- I explained approximate transporter occupancy at prescribed dose (e.g., serotonin ~80–90%). Doctor initials:
- We discussed how high occupancy may relate to emotional blunting and withdrawal severity. Doctor initials:
Part 5 — Side Effects discussed
- Emotional blunting / reduced empathy. Doctor initials:
- Sexual dysfunction (desire, arousal, orgasm). Doctor initials:
- Blood pressure changes / monitoring plan. Doctor initials:
- Sleep disturbance, sweating, headaches, dizziness. Doctor initials:
- Weight change (gain or loss). Doctor initials:
- Serious risks: serotonin syndrome, seizures, heart rhythm changes. Doctor initials:
Part 6 — Pregnancy & Postpartum
- Risks in pregnancy (neonatal adaptation, preterm/low birth weight) discussed. Doctor initials:
- Breastfeeding: drug transfer via milk & possible infant withdrawal discussed. Doctor initials:
- Impact on maternal bonding/emotional responsiveness discussed. Doctor initials:
Part 7 — Monitoring & Follow-Up
- First follow-up scheduled within weeks.
- Contact if symptoms worsen/adverse effects:
- Safety plan (how family responds to red flags) reviewed. Doctor initials:
