A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia

NCT03319953 ↗

Phase 2 Completed 23 enrolled Neurocrine Biosciences Takeda · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.

Timeline

Start: 2017-12-21
Primary completion: 2019-09-11
Completion: 2019-11-06

Outcome

Missed primary endpoint

paper There was no significant effect of TAK-041 compared with placebo on BACS score at either timepoint. PMID 40817174 ↗

Publications

Hawkins PCT, Schwarz AJ, Stone JM, Pepper F, Gilleen J, Gijsen S, Mazibuko N, Arkilo D, Yin W, Wu J, Khudyakov P, Behrje R, Rosen L, Posener J, Mehta MA, Laurenza A. The GPR139 agonist TAK-041 produces time-dependent alterations to cerebral blood flow and reward system function in patients with schizophrenia: a randomised placebo-controlled trial. Psychopharmacology (Berl). 2026 Apr;243(4):819-829. doi: 10.1007/s00213-025-06884-x. Epub 2025 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ZELATRIAZIN	Small molecule	40 mg	Oral
Subject	ZELATRIAZIN	Small molecule	160 mg	Oral
Background	Asenapine	Other / unclassified	—	—
Background	Iloperidone	Small molecule	—	—
Background	Lurasidone	Small molecule	—	—
Background	Olanzapine	Small molecule	—	—
Background	Paliperidone	Unknown	—	—
Background	Quetiapine	Small molecule	—	—
Background	Risperidone	Other / unclassified	—	—
Background	Ziprasidone	Small molecule	—	—