Proof of activity of TAK-041 in schizophrenia
Research type
Research Study
Full title
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 Second Generation Antipsychotics in Subjects With Stable Schizophrenia
IRAS ID
228739
Contact name
James Stone
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd.
Eudract number
2017-001084-20
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This is a study to investigate the treatment of symptoms of schizophrenia with TAK-041 (the study medication). Schizophrenia is a chronic, debilitating psychiatric disorder that affects up to 1 percent of people throughout the world and places a substantial burden on patients, their families, and society. Symptoms can include social withdrawal (asociality), decreased motivation (amotivation), impaired ability to communicate, lack of pleasure in things once found pleasurable (anhedonia) and marked cognitive impairment. Antipsychotics are effective in treating the positive symptoms of schizophrenia (e.g., delusions and hallucinations) but are less effective in treating disabling cognitive impairment and negative symptoms. To date there are no approved medications addressing negative symptoms or cognitive impairment associated with schizophrenia.
TAK-041 is a newly developed medication that has been previously administered to healthy volunteers. Recently, research in animals has suggested that TAK-041 may improve some of the negative symptoms of Schizophrenia mentioned above. This study will enrol up to 32 eligible participants with schizophrenia, who are aged 18-60 years and on a stable dose of antipsychotic medication. They will be assigned randomly to 1 of 4 treatment sequences, consisting of two evaluation periods. During one evaluation periods, participants will receive either 20 mg TAK-041 or 40mg TAK-041 and during the other they will receive a placebo (a suspension that looks the same as TAK-041 but does not have active medication in it). They will take the assigned medication on the first day of each period, and continue to take their current antipsychotic medication throughout the whole study.
The participants will visit the study site about 11 times during the study over a period of roughly 6 ½ months. During these visits they will undergo various study procedures to assess the effectiveness of the study medication.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0195
Date of REC Opinion
16 Aug 2017
REC opinion
Further Information Favourable Opinion