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Home › Conditions › Agitation

Agitation

0 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Agitation

16 trials tracked for Agitation: 12 in phase 3 or 4 and 4 with published results. The most-cited published study has 80 citations.

16Trials tracked
12Phase 3 & 4
0Recruiting
4With published results
Phase distribution
Phase 4 6 Phase 3 6 Phase 2 3 Other / NA 1
  1. Phase 4 Treating Acutely Agitated Patients With Asenapine Sublingual Tablets Completed · 80 cited
  2. Phase 3 Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia Completed · 30 cited
  3. Phase 3 Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial) Completed · 22 cited
  4. Phase 4 TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting Completed · 2 cited
  5. Phase 4 A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room Completed
  6. Phase 4 Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure Completed
Show 10 more trials
  1. Phase 4 Dexmedetomidine to Prevent Agitation After Free Flap Surgery Completed
  2. Phase 4 Antipsychotic Discontinuation in Alzheimer's Disease Completed
  3. Phase 3 Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children Completed
  4. Phase 3 Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) Completed
  5. Phase 3 Citalopram for Agitation in Alzheimer's Disease Completed
  6. Phase 3 Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia Completed
  7. Phase 2 Treatment of Psychosis and Agitation in Alzheimer's Disease Completed
  8. Phase 2 Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease Completed
  9. Phase 2 Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium Completed
  10. N/A Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit Completed

Showing the 16 most-cited and recently-updated of 16 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Agitation: what the trials found

Dexmedetomidine has been evaluated across multiple trials for the management of agitation in various clinical settings [1, 6, 10, 15]. Specifically, a sublingual film formulation of dexmedetomidine (BXCL501) demonstrated significant reductions in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score from baseline 8, including for first episodes of agitation 9.

Other pharmacological interventions include olanzapine, which showed significant improvements in both PANSS-EC scores and ACES scores 120 minutes after administration 11. Citalopram was associated with statistically significant improvements in the NeuroBehavior Rating Scale (NBRS) for agitation and the Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation (CGIC) 12.

Risperidone demonstrated a reduction in relapse rates by weeks 32 and 48 compared to controls 7. Other agents investigated include asenapine 2, quetiapine 5, and a combination of haloperidol, promethazine, and chlorpromazine 3. Propofol was evaluated for agitation but did not show statistically significant differences in duration of mechanical ventilation, MICU stay, or vasopressor support 4.

Recent results — preliminary, needs further review

  • AVP-923-20 showed a statistically significant reduction in the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain and total NPI scores over a 70-day period; however, changes in individual NPI domains were not statistically significant 13.
  • Lithium was evaluated for agitation but did not show statistically significant improvements in NPI Agitation/Aggression scores or clinical responder rates 14.

For the clinician treating this condition

  • Dexmedetomidine and its sublingual formulation (BXCL501) are established interventions for reducing agitation, with the latter showing significant impact on PEC scores [1, 8, 9].
  • Olanzapine and citalopram have demonstrated statistically significant improvements in validated agitation scales (ACES, NBRS, CGIC) [11, 12].
  • Risperidone is associated with lower relapse rates in patients experiencing agitation 7.

AI synthesis of 11 cited trials, updated Aug 20, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
No published articles yet for this condition. Check back soon.