Autopsy report · NCT01111539

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

“The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months before it started.
• Ran for about 1 year 2 months before it stopped.
• 211 participants enrolled.
• Results were posted on the registry 10 years 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor type

Industry

Conditions

Major Depressive Disorder (MDD)

Interventions

Escitalopram; Aripiprazole; Blinded capsule

Participants

211

Sites

62

Countries

Estonia, Finland, Germany, India, Italy, Mexico, South Korea, Taiwan, United States

Trials that died the same way

• An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
  “The study was terminated early due to sponsor decision unrelated to safety or efficacy findings” (83% match in meaning)
• A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
  “The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.” (82% match in meaning)
• Study of Ataluren (PTC124) in Hemophilia A and B
  “Study was terminated early due to Sponsor decision and not reflective of adverse safety findings.” (81% match in meaning)
• Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
  “Study was terminated by Sponsor; the decision was not due to any safety findings.” (80% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (80% 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.