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    Summary
    EudraCT Number:2014-001541-24
    Sponsor's Protocol Code Number:NeuroIPT-1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-04
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2014-001541-24
    A.3Full title of the trial
    Neuroenhancement of Interpersonal Psychotherapy in Major Depression
    Augmentation von Interpersoneller Psychotherapie durch D-Cycloserin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neuroenhancement of Interpersonal Psychotherapy in Major Depression
    Augmentation von Interpersoneller Psychotherapie durch D-Cycloserin
    A.4.1Sponsor's protocol code numberNeuroIPT-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Freiburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Freiburg
    B.5.2Functional name of contact pointUniversity Medical Center Freiburg
    B.5.3 Address:
    B.5.3.1Street AddressHauptstrasse 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.4CountryGermany
    B.5.6E-mailchristoph.nissen@uniklinik-freiburg.de
    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 Yes
    D.2.1.1.1Trade name Cycloserine
    D.2.1.1.2Name of the Marketing Authorisation holderKing Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.1Product nameCycloserin-Kapseln
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCYCLOSERINE
    D.3.9.1CAS number 68-41-7
    D.3.9.4EV Substance CodeSUB06863MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, hard
    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
    Major Depression (ICD-10; F32.2/F33.2)
    Depressive Störung (ICD-10; F32.2/F33.2)
    E.1.1.1Medical condition in easily understood language
    Disorder in which the fundamental disturbances are a change in affect or mood to depression and a usually accompanied change in the overall level of activity.
    Störung deren Hauptsymptome eine Veränderung der Stimmung oder der Affektivität zur Depression hin und eine Veränderung des allgemeinen Aktivitätsniveaus sind.
    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
    Investigate the hypothesis that the efficacy of Interpersonal Psychotherapy (IPT) can be enhanced by co-administration of the NMDA-receptor agonist D-cycloserine in patients with major depressive disorder.
    Untersuchung der Hypothese, dass die Effektivität Interpersoneller Psychotherapie (IPT) durch die behandlungsbegleitende Gabe des NMDA-Rezeptor Agonisten D-Cycloserin bei Patienten mit depressiver Störung erhöht werden kann.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    "Not applicable"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Major depressive disorder (ICD-10: F32.2 and F33.2)
    Inpatients at the Department of Psychiatry and Psychotherapy, Freiburg
    Score of ≥15 on the 21-item Hamilton Rating Scale for Depression (HAMD)
    20-60 years of age
    Ability to provide informed consent
    Normal or corrected-to-normal vision
    Absence of any exclusion criteria
    Depressive Störung (ICD-10: F32.2/F33.2)
    Stationäre Patienten an der Klinik für Psychiatrie und Psychotherapie, Freiburg
    Wert ≥15 auf der 21-item Hamilton Rating Scale for Depression (HAMD)
    Alter von 20–60 Jahre
    Fähigkeit zur informierten Einwilligung
    Normales oder korrigiertes Sehvermögen
    Abwesenheit von Ausschlusskriterien
    E.4Principal exclusion criteria
    Hypersensitivity to D-cycloserine
    Neurological disorders including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome
    Metallic implants
    Present pregnancy
    DSM-V axis I disorder (lifetime) apart from major depression, such as schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, bipolar disorders, primary anxiety or obsessive compulsive disorder, mental retardation, signs of impaired cognitive functioning
    Acute suicidality
    Psychotic features of MDD
    Lifetime history for drug/alcohol dependence, or drug/alcohol abuse within the past year
    Medication with any anxiolytic or antipsychotic drug, except antidepressants for patients
    Medical conditions including severe cardiac, liver, kidney, endocrine (e.g., diabetes), hematologic disorders (e.g., porphyria or any bleeding abnormalities), other impairing or unstable medical condition or impending surgery
    Inability to read or understand the study forms and agree to informed consent.
    Left-handedness
    Hypersensibilität auf D-Cycloserin
    Neurologische Störung, insb. epileptische Anfälle oder Gehirnverletzungen, Enzephalitis oder ein anderes hirnorganisches Syndrom in der Vorgeschichte
    Metallimplantate
    Schwangerschaft
    DSM-V Achse I Störung (ausgenommen Depression)
    Akute Suizidalität
    Psychotische Episoden im Rahmen der Depression
    Substanzmissbrauch oder -abhängigkeit in der Vorgeschichte
    Medikation mit Benzodiazepinen oder Antipsychotika
    Somatische Erkrankung (z.B. relevante kardiovaskuläre, nephrologische,endokrinologische oder hämatologische Erkrankungen), andere instabile Gesundheitsprobleme oder eine anstehende Operation
    Unfähigkeit zu Lesen, die Studieninhalte zu verstehen oder eine informierte Einwilligung abzugeben
    Linkshändigkeit
    E.5 End points
    E.5.1Primary end point(s)
    Change in depressive symptomatology as assessed by HAMD at week 8 compared to baseline.
    Veränderung der depressiven Symptomatik. Vergleich des HAMD-Werts vor und nach Behandlung (Woche 8).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (beginning of treatment) vs. after treatment (week 8)
    Vor Behandlung verglichen mit nach der Behandlung (Woche 8)
    E.5.2Secondary end point(s)
    Rates of response (50% reduction on the HAMD) and remission (<10 on the HAMD) at week 8, self-reported outcomes of depressive symptoms as assessed by the Beck Depression Inventory (BDI).
    Change in inducability of LTP-like synaptic plasticity (changes of size of TMS-evoked MEP-amplitudes before vs. after PAS) at week 1 (first DCS-capsule) and at week 8 compared to baseline.
    Changes in declarative memory (word-pair task),working memory (digit span) and attentional performance (TAP-Alertness ).
    Anteil des Ansprechens auf die Therapie (50% Reduktion des HAMD-Wertes) und der Remission (HAMD-Wert <10) nach Woche 8.
    Selbstbeurteilung der depressiven Symptomatik durch das Beck-Depressions-Inventar (BDI).
    Veränderung der Induzierbarkeit LTP-ähnlicher synaptischer Plastizität (Veränderung der Amplitudenhöhe der durch TMS ausgelösten MEP vor und nach PAS) in Woche 1 (erste DCS-Kapsel) und in Woche 8 verglichen mit vor Behandlungsstart.
    Veränderung deklarativen Lernens, der Arbeitsgedächtnis- und der Aufmerksamkeitsleistung vor Behandlung und am Ende der Behandlung.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (beginning of treatment) vs. after treatment (week 8)
    Vor Behandlung verglichen mit nach der Behandlung (Woche 8)
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    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) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 28
    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 No
    F.3.2Patients Yes
    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 state28
    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)
    Exluded participants as well as participants completing the study will continuesly receive standard therapy. Usually patients will be retransferred to their local psychiatrist and/or psychotherapist in private practice. Alternatively patients will get amubulantory or stationary treatment at the University Medical Center Freiburg, Klinik für Psychiatrie und Psychotherapie.
    Studienteilnehmer, die vorzeitig oder gemäß Prüfplan aus der Studie ausscheiden, werden im Rahmen der Standardbehandlung weiterversorgt. Üblicherweise werden die Patienten wieder von ihrem niedergelassenen Psychiater und/oder Psychotherapeuten weiterversorgt werden. Alternativ besteht die Möglichkeit, im Anschluss an die Studie eine ambulante oder stationäre Behandlung in der Universitätsklinik Freiburg, Klinik für Psychiatrie und Psychotherapie, vorzunehmen.
    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 Decision2016-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
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