Table 1

Reporting of adverse events in publications from the TADS

Reported eventStage 1 (12 weeks)Stage 2+3 (36 weeks)Stage 4 (88 weeks)
TADS team6 Emslie et al 12 Kennard et al 13*May et al 14TADS team15 Kennard et al 16Vitiello et al 17§TADS team18
Harm-related adverse eventxxx
Suicide-related adverse eventxxxxxxx
Attempted suicidexxxxxx
Homicidalityxx
Maniaxxxx
Hypomaniaxxx
Elevated moodxx
Trouble attention/concentrationx
Racing thoughtsx
Excessive talking/talking very fastx
Increase in activitiesx
Impulsivityx
Hypersensitivity**xx
Irritabilityxxx
Angerxx
Worsening of depressionxxxxxx
Psychomotor
Guilt
Mood
Interest
Cryingxx
Agitationxx
Akathisiaxx
Nervousnessxx
Restlessnessxx
Hyperactivityxx
Panic attacksxx
Anxietyxx
Excessive sweatingx
Difficulty breathingx
Hearing problemsx
Somnolence/feeling drowsyxx
Insomnia/sleeplessnessxxx
Sleepxx
Nightmarexx
Night sweatsx
Sedationxx
Fatiguex
Tremorxx
Behaviour/feeling abnormalxx
Social problemsxx
Headachexx
Upper abdominal painxx
Stomach painx
Diarrhoeaxx
Influenza/sinusitisx
Cold, sore throat, cough/wheezex
Allergiesx
Dry mouthx
Nausea/vomitingxx
Feverx
Muscle aches or crampsx
Joint painx
Numbness or tingling arms or legsx
Weight
Chest painx
Racing/pounding heart, skip beatsx
Urination frequency or painx
Constipation, feeling bloatedx
Skin rash/hivesx
  • *Reporting limited to responders subgroup, regardless of treatment arm.

  • †Reporting limited to subgroup of patients seeking attrition prevention.

  • ‡Reporting limited to ITT placebo group.

  • §Reporting limited to patients with a suicidal event.

  • ¶Reported as residual symptoms of depression.

  • **Understood as mood hypersensitivity.

  • ITT, intention to treat; TADS, Treatment for Adolescents With Depression Study.