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    Summary
    EudraCT Number:2005-004525-26
    Sponsor's Protocol Code Number:DAD-Study
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-08
    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 number2005-004525-26
    A.3Full title of the trial
    Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial
    A.3.2Name or abbreviated title of the trial where available
    DAD
    A.4.1Sponsor's protocol code numberDAD-Study
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number89333241
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRuhr Universität Bochum
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Sertralin-Hexal 50mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG, Industriestraße 25, 83607 Holzkirchen
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsertraline
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with insulin-treated type 1 or type 2 diabetes mellitus with depression and HbA1c-value >7,5% ICD E14.90 with F32
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10022497
    E.1.2Term Insulin-dependent diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the planned study is to evaluate the efficacy of a diabetes-specific CBT combined with diabetes education versus a sustained treatment with SSRI (sertraline) combined with diabetes education in high-risk patients with poorly controlled insulin-treated type 1 or type 2 diabetes mellitus and depression. Principal research question: Does a diabetes-specific psychotherapy (CBT) or antidepressant medication (sertraline) improve long-term glycaemic control in patients with poorly controlled diabetes and depression? Primary hypothesis: CBT leads to a greater proportion of patients achieving clinically important improvement of glycaemic control when compared with sertraline at the one-year follow-up in patients who initially responded to short-term therapy (CBT or sertraline) with regard to improvement in depression.
    E.2.2Secondary objectives of the trial
    To provide clear scientific evidence for the currently open questions regarding whether the two most established treatments (SRRI and CBT) for patients with depression but without additional somatic diseases can be applied to high-risk patients with poor metabolic control of insulin-treated diabetes and comorbid depression; and wether long-term treatment (sustained sertraline treatment) is necessary to achieve and maintain remission. Secondary hypothesis: CBT and sertraline are both effective in terms of remission of depression after 12 weeks in an open label trial as well as at the one-year follow-up. Secondary endpoints: (a) remission of depression: no longer fulfilling the DSM-IV-TR criteria for depression according to the SCID41, and depression score Hamilton Rating Scale -Interview <= 7; (b) improvement of depression (>/= 50% reduction of (HAMD-baseline score); (c) improved generic HRQoL, per SF-3642; and (d) decreased problems in daily living with diabetes, per PAID43.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 1 or type 2 diabetes mellitus diagnosed at least 12 months before entering the trial • insulin treatment for at least the preceding 6 months • 21 to 69 years of age • poor glycaemic control (HbA1c level > 7,5%) • current major depression (DSM-IV-TR criteria) • residence near the coordination institution where CBT treatment will take place (<1 hour access). • Ability of subject to understand character and individual consequences of clinical trial • Written informed consent must be available before enrollment in the trial • Women with child bearing potential in the sertraline group: Women will be informed that women with childbearing potential in the sertraline group should use highly effective birth control methods (e.g. combined oral contraceptives, acyesis, im plants).
    E.4Principal exclusion criteria
    • Clinically significant suicide risk or history of attempted suicide in the last 12 months • history of schizophrenia • psychotic symptoms • bipolar disorder • organic brain syndrome or dementia • alcohol or substance abuse or dependence in the past 6 months • insufficient ability to understand German • psychotherapy in the preceding 3 months • Pregnant or lactating patient • history of convulsion or seizure disorder • significant liver enzyme elevations: SGOT (aspartate aminotransferase, AST) or SGPT (alanine aminotransferase, ALT) above 3-fold of normal upper limits • significant other laboratory findings (physician’s decision). • Current use of mood stabilizers, neuroleptics, anti-epressants, or benzodia-epines except for (1) continuation of unchan-geable stable amitriptyline gi-ven to treat painful diabetic neuropathy up to 50mg per day, and (2) short-term use of benzo-diazepines (less than 2 weeks), and (3) low-potency neuroleptics in low doses (less than 300mg chlorpromazine dose equiva-lents per day) • pre-treatment with reversible MAO inhibitors within the past 2 weeks • current, unchangeable co-medication with tryptophan, fenfluramine, or serotonin agonists (triptans). Continuation of stable treatment with thyroid hormones is permitted. • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product • participation in other clinical trials and observation period of competing trials, respectively.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of glycaemic control (minimum 1% decrease in HbA1c value). HbA1c tests measure a patient’s average glycaemia over the preceding 2 to 3 months and, thus, assess treatment efficacy. This measurement is considered essential to determine whether a patient’s metabolic control has been reached and maintained within the target range23. A 1% decrease in HbA1c value corresponds approximately to the difference between intensively and conventionally treated diabetes patient groups (0.9%) in the UKPDS trial5. A difference of this magnitude can be considered clinically significant because it is recognised to reduce the risk of development and progression of diabetic microvascular complications, as was demonstrated in the UKPDS trial5. HbA1c values for all patients will be measured in the bioscientia Laboratory by the validated method of high-performance liquid chromatography (HPLC). The bioscientia Laboratory works according to GLP (Good Laboratory Practice) and is accredited by CAP (College of American Pathologists).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    cognitive behavioural therapy
    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 concerned32
    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 Information not present in EudraCT
    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
    End of the trial is the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 350
    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 Decision2006-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-17
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