An experimental trial to investigate a new medicine (drug), TAK-041, in patients with schizophrenia
- Conditions
- SchizophreniaMedDRA version: 20.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-001084-20-GB
- Lead Sponsor
- Takeda Development Centre Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
1. The subject understands the study procedures and agrees to participate by providing written informed consent.
2. The subject is willing and able to comply with all study procedures and restrictions.
3. The subject is judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and prior to administration of the initial dose of study drug/invasive procedure.
4. The subject is male or female and 18 to 60 years of age, inclusive, at the Screening Visit.
5. A female subject of childbearing potential who is sexually active with a nonsterilized male partner must agree to use 2 highly effective methods of contraception from signing of informed consent throughout the duration of the study and for 85 days after the last dose or she is postmenopausal.
6. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential must agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 145 days after last dose. The female partner of a male subject should also be advised to use a highly effective/effective method of contraception.
7. The subject is on a stable dose of an antipsychotic for at least 2 months as documented by medical history and assessed by site staff (other than those excluded in Table 7a of the protocol).
8. The subject meets schizophrenia criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the Mini International Neuropsychiatric Interview (MINI).
9. The subject has PANSS total score =90 and PANSS negative symptom factor score (NSFS; Sum of PANSS N1, N2, N3, N4, N6, G7 and G16) = 15 at screening and baseline (Day -1).
10. The subject has stable screening and baseline (Day -1) PANSS and NSFS total scores (<20% change).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Has participated in another investigational trial within 4 weeks prior to the pretrial/screening visit. The 4-week window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
2. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the Clinical Site or the Sponsor.
3. Has a history of cancer (malignancy).
4. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
5. Has a positive alcohol and/or positive drug screen at Screening or Day -1.
6. Has a positive pregnancy test.
7. Is a lactating/nursing female.
8. Is positive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen (confirmatory testing is allowed; most sensitive test should take precedence).
9. The subject has abnormal screening or baseline laboratory values (> ULN for the respective serum chemistries) of ALT, AST, TBILI, ALP, GGT, confirmed upon repeat teasting, 5’-nucleotidase (screening only) and/or abnormal urine osmolality, confirmed upon repeat testing.
10. Had major surgery, or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial/Screening Visit.
11. Is unable to refrain from or anticipates the use of any medication (except those prescribed), including prescription and nonprescription drugs or herbal remedies beginning approximately 7 days prior to administration of the initial dose of trial drug, throughout the trial (including washout intervals between treatment periods), until the Final Visit. Medications that are permitted are listed in Section 7.3.
12. Meets DSM-5 criteria for substance use disorder or history of alcohol abuse within 1 month prior to Screening Visit
13. Has a history of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session.
14. Fulfills any of the MRI contraindications on the site standard radiography screening document.
15. Has a history in the last year or is currently receiving treatment with clozapine.
16. Has a current diagnosis of a significant psychiatric illness other than schizophrenia, per DSM-5 and is in an acute phase/episode.
17. Has a risk of suicide according to the investigator’s clinical judgment (eg, per C-SSRS positive answers on questions 4 or 5 for the last 6 months or has made a suicide attempt within 6 months prior to screening visit).
18. Is unsuitable for inclusion in the study in the opinion of the investigator or sponsor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To determine whether motivation/reward deficits observed in schizophrenia are attenuated by add-on TAK-041 administration to antipsychotics in subjects with stable schizophrenia<br><br>- To determine whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in subjects with stable schizophrenia.;Secondary Objective: To determine safety and tolerability of TAK-041 as add on therapy to antipsychotics in subjects with stable schizophrenia;Primary end point(s): - Change from placebo in BOLD signal in the average of left and right ventral striatum activation in the Monetary Incentive Delay (MID) Reward Task at first testing after TAK-041 administration (Day 1).<br><br>- Change from placebo in the BACS composite score at second testing after TAK-041 administration (Day 14).;Timepoint(s) of evaluation of this end point: Day 1 and Day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Percentage of subjects who experience at least 1 treatment-emergent adverse event.<br>- Percentage of subjects who meet the markedly abnormal criteria for safety laboratory tests at least once postdose.<br>- Percentage of subjects who meet the markedly abnormal criteria for vital sign measurements at least once postdose.<br>- Percentage of subjects who meet the markedly abnormal criteria for safety ECG parameters at least once postdose.<br>- Columbia-Suicide Severity Rating Scale at all time points assessed.;Timepoint(s) of evaluation of this end point: Throughout the study