Cognitive dysfunction Major depressive disorder (MDD)
Conditions
Interventions
Product Code: Lu AA21004
Pharmaceutical Form: Capsule
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: Lu AA21004
Other descriptive name: Lu AA21004
Concentration unit: mg milligram(s)
C
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is able to read and understand the Subject Information Sheet and Informed Consent Form. - The subject and the physician have signed the study-specific Informed Consent Form. No study-related procedures, including any screening procedures, may be performed before the physician has obtained written informed consent from the subject. - The subject is fluent in English. - The subject is a man or woman. - If woman, the subject must: -agree not to try to become pregnant from Screening until after the Follow-up Visit, AND - use adequate, highly effective contraception (defined as those that result in a low failure rate [that is, 25 years of age and 18 kg/m2 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has taken OTC medicine within 48 hours prior to safety baseline. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety. 2. The subject has a resting systolic blood pressure 150 mmHg or a resting diastolic blood pressure 90 mmHg. An out-of-range resting systolic blood pressure may be repeated once if a medically valid reason is present, for example, the subject suffers from white-coat hypertension or has just come from low outdoor temperatures. The medically valid reason must be documented and signed by the investigator or study physician. 3. The subject has a resting pulse 100 bpm. For subjects in good physical condition, the lower limit is 250 ms -a QRS interval >130 ms -a QTcF interval >450 ms (for men) or >470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR0.33) 5. The subject has a value of thyroid stimulating hormone (TSH) outside the normal range. 6. The subject has one or more clinical safety laboratory test values outside the reference range, based on the blood and urine samples that are of potential risk to the subject’s safety, or the subject has: -a serum creatinine value >1.5 times the upper limit of the reference range -a serum total bilirubin value >1.5 times the upper limit of the reference range -a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 times the upper limit of the reference range 7. The subject has a history of alcohol or other substance abuse or dependence (DSM-IVTR™ criteria) within the last 2 Years. 8. In the opinion of the Investigator the subject is at risk of suicide. 9. The subject uses hypnotics regularly. 10. The subject has a positive reading on the drugs of abuse test (opiates, methadone, cocaine, amphetamines (including ecstasy), barbiturates, benzodiazepines and cannabinoids). 11. The subject consumes more than 8 cups of standard caffeinated drinks (tea, instant coffee etc.) or 6 cups of stronger coffee or other drinks containing methylxanthines (such as coca cola or Red Bull) per day. 12. The subject smokes > 5 cigarettes per day. 13. The subject is left-handed. 14. The subject is colour blind. 15. The subject has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the cognitive tests. 16. The subject is diagnosed with reading disability (dyslexia). 17. The subject is currently receiving formal cognitive or behavioural psychotherapy or systematic psychotherapy, or plans to start such therapy during the study. 18. The subject has been treated with electroconvulsive therapy within 12 months prior to Screening Visit. 19. The subject has taken any investigational products within 3 months prior to the first dose of IMP. 20. The subject has previously been dosed with Lu AA21004. 21. The subject has known hypersensitivity to any of the IMPs or their excipients. 22. The subject has a history of severe drug allergy or hypersensitivity. 23. The subject is pregnant or breastfeeding. 24. The subject has previous experience of the emotional test battery experimental procedures. 25. The subject has any current
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with executive function (working memory) during performance of the N-back task. The regions of interest are within the prefrontal cortex and anterior cingulate • to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with spatial memory during performance of the Arena task., The region of interest is hippocampus • to evaluate the effects of Lu AA21004 compared to placebo in subjects remitted from depression on the BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during working memory and planning performance (N-back and Arena task);Secondary Objective: Performance • to explore the effects of Lu AA21004 compared to placebo on cognitive performance including executive function, memory, speed of processing, attention and cognitive flexibility measured using N-back, Arena, DSST, RAVLT, TMT A/B and Implicit IDED • to evaluate the effects of Lu AA21004 compared to placebo on emotional processing using the P1vital® Oxford Emotional Test Battery (ETB) • to evaluate the baseline characteristics of cognitive performance (N-back, Arena, DSST, RAVLT, TMT A/B, IDED) and BOLD signal in fMRI (during N-back and Arena) in subjects remitted from depression compared to controls • to compare the effects of Lu AA21004 to placebo on cognitive performance (N-back, Arena, DSST, RAVLT, TMT A/B, IDED), processing (ETB) and BOLD signal in fMRI (during N-back and Arena) in subjects remitted from depression compared to controls;Primary end point(s): Imaging Endpoints •N-Back: BOLD fMRI activity during the 0 (control), 1, 2 and 3 back conditions of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
United Kingdom
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed