Autopsy report · NCT01340690

Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder

“The sample size of the planned interims analysis was achieved”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 6 years before it stopped.
• 284 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Johannes Gutenberg University Mainz

Sponsor type

University, hospital or other

Conditions

ADHD

Interventions

ω-3 fatty acids suspension; placebo suspension

Participants

284

Sites

5

Countries

Germany

Trials that died the same way

• The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
  “Interim analysis provided enough data” (76% match in meaning)
• Verapamil vs Steroid to Prevent Keloid Recurrence
  “Objective of study achieved after interim analysis.” (75% match in meaning)
• ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients
  “Lack of effect in interim analysis” (72% match in meaning)
• Alprostadil in Maculopathy Study (AIMS)
  “Interim Analysis: Optimization of study design required.” (71% match in meaning)
• Liberty Analyzer WBC System: Reference Interval Study
  “For interim analysis.” (70% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.