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    Summary
    EudraCT Number:2011-001839-23
    Sponsor's Protocol Code Number:14137A
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-001839-23
    A.3Full title of the trial
    Interventional randomised, double-blind, parallel-group,
    placebo-controlled, exploratory study investigating the
    effects of Lu AA21004 on cognition and BOLD fMRI
    signals in subjects remitted from depression and controls
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.4.1Sponsor's protocol code number14137A
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/282/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 36 301311
    B.5.5Fax number+45 36 301940
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code Lu AA21004
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeLu AA21004
    D.3.9.3Other descriptive nameLu AA21004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cognitive dysfunction
    Major depressive disorder (MDD)
    E.1.1.1Medical condition in easily understood language
    Cognitive dysfunction
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • 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)
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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, <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.
    E.4Principal 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 <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 Axis I disorder (DSM-IV-TR™ criteria) assessed by the SCID-I.
    26. The subject has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
    27. The subject suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
    28. The subject has a history of cancer, except for basal cell or Stage 1 squamous cell carcinoma of the skin which has been in remission for at least 5 years prior to the first dose of IMP.
    29. The subject has a history of moderate or severe head trauma (for example, loss of consciousness for more than 1 hour) or other neurological disorders or systemic medical diseases that are, in the opinion of the investigator, likely to affect central nervous system functioning.
    30. The subject has a current diagnosis or history of stroke or Transient Ischemic Attack (TIA).
    31. The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of IMP.
    32. The subject suffers from claustrophobia or needle phobia.
    33. The subject is unable to comply with Magnetic Resonance Declaration.
    34. The subject has a clinically relevant structural brain abnormality as determined by MRI.
    E.5 End points
    E.5.1Primary end point(s)
    Imaging Endpoints
    •N-Back: BOLD fMRI activity during the 0 (control), 1, 2 and 3 back conditions of the task.
    •Arena Task: BOLD fMRI activity while performing the encoding and retrieval trials.
    •Resting State: BOLD fMRI activity in resting state in fMRI-derived networks
    •ASL: Perfusion level (absolute inflow of arterial blood)

    Cognitive Performance Endpoints
    •N-Back: Accuracy, Individual average reaction time, d’
    •Arena Task: Average distance from the pole in the retrieval phase.
    •DSST: Number of correct symbols (change from baseline) Day 13
    •RAVLT: Acquisition, delayed recall (Change from baseline) Day 13
    •Trail Making A/B: Time to completion using both the TMT A and TMT B (change from baseline) Day 13
    •Implicit IDED: Vigilance (Reaction time), Vigilance (accuracy) Day 13
    •EMEM: Total number of words recalled for each valence, Commission errors
    •EREC: False alarms, hits, d’, Response bias, Individual average reaction time for (ms) correct answers
    •FERT: Accuracy, Individual average reaction time, d’, Number of misclassifications for each emotion,
    Response bias
    •FDOT: Individual average reaction time, Vigilance scores, Accuracy
    •ECAT: Number of words categorised as like and disliked

    Scales Endpoints
    •SCID-I – at baseline
    •NART IQ - at baseline (= at screening)
    •HAM-D17 total score – at baseline and change from baseline
    •BDI-II total score – at baseline and change from baseline
    •STAI subsore of State – at baseline and change from baseline
    •STAI subsore of Trait – at baseline and change from baseline
    •PANAS subscore of PA– at baseline and change from baseline
    •PANAS subscore of NA– at baseline and change from baseline
    •PDQ total score and subscales scores – at baseline and change from baseline
    •BRIEF-A – at baseline and change from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to the protocol “Summary of study procedures and assessments” for evaluation timepoints
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 96
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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