The study to investigate the effect of Investigational Drug Lu AA21004 or placebo (a drug identical in appearance but does not contain Lu AA21004) on the way the brain works and memory of people who suffered depression in the past, and healthy volunteers.
- Conditions
- Cognitive dysfunctionMajor depressive disorder (MDD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-001839-23-GB
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 101
- 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, <1% per year] when used consistently and correctly, for example, implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, vasectomised partner), OR
-have had her last natural menstruation at least 24 months prior to baseline, OR
-have been surgically sterilised prior to Screening, OR
-have had a hysterectomy prior to Screening, OR
-have a partner who has been surgically sterilised prior to baseline, OR
-not be sexually active with opposite gender
- The subject is >25 years of age and <55 years of age at the Screening Visit.
- The subject has a BMI >18 kg/m2 and <36 kg/m2 at the Screening Visit.
- The subject has a total HAM-D17 score = 7
Subject remitted from depression must:
- Be in remission from recurrent depression (DSM-IV-TRTM criteria, classification code 296.3x) having suffered from at least two previous MDEs.
- Have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression (e.g. cognitive behaviour therapy) for a previous MDE.
- Report present subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
- Have not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to Screening Visit.
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 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 <91 mmHg or >150 mmHg or a resting diastolic blood pressure <51 mmHg or >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 <51 bpm or >100 bpm. For subjects in good physical
condition, the lower limit is <45 bpm.
4. The subject has any of the following:
-an abnormal ECG that is, in the investigator’s opinion, clinically significant
-a PR interval >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method