E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized anxiety disorder (GAD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018105 |
E.1.2 | Term | Generalized anxiety disorder |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess whether duloxetine 30 to 120 mg once daily is superior to placebo in the treatment of elderly patients (≥65 years old) with Generalized anxiety disorder (GAD). |
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E.2.2 | Secondary objectives of the trial |
Efficacy, including assessment of: - Mean improvement on the Sheehan Disability Scale (SDS) Global Functional Impairment score. - Response and remission rates - Patients’ role functioning and quality of life
Safety and tolerability. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol Sample Storage Addendum F1J-MC-HMGF(1.0) Duloxetine Versus Placebo in the Treatment of Elderly Patients with Generalized Anxiety Disorder
Protocol Addendum (1): 26 March 2010
The primary objective is to collect and store sample(s) of whole blood for research into genetic variants in DNA associated with generalized anxiety disorder (GAD). |
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E.3 | Principal inclusion criteria |
[1] Male and female outpatients at least 65 years old presenting with GAD based on the DSM-IV TR diagnostic criteria. The patient must suffer from GAD and not from an adjustment disorder or anxiety disorder NOS. Symptoms of GAD should not be situational in nature. [2] Have a MMSE score of at least 24 at Visit 1. [3] Have a CGI-Severity score of ≥4 at Visit 1 and Visit 2. [4] Have a CAS score of ≥9, no item in the RDS may be >3, and the CAS score must be greater than the RDS at Visit 1. [5] Have a HADS anxiety subscale score of ≥10 at Visit 1. |
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E.4 | Principal exclusion criteria |
[8] Have any current and primary DSM-IV TR Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia. [9] The presence of an Axis II disorder, or history of antisocial behavior, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance. [10] Have organic mental disorder or mental retardation diagnosis. [11] Currently use benzodiazepine or have used benzodiazepine 14 days prior to Visit 2. [12] Are judged clinically to be at serious risk of harm to self or others. [15] Have a history of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV TR) within the past 6 months. [16] Excessively use caffeine, in the opinion of the investigator. [17] Have a positive UDS for any substances of abuse at Visit 1. [18] Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those that, in the judgment of the investigator, indicate a serious medical problem. [19] Have any acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C). [20] Have an abnormal thyroid-stimulating hormone (TSH) concentrations (outside the reference range of the performing laboratory). [21] Have initiated psychotherapy or changed intensity of psychotherapy or other non-drug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study. [22] Have taken any excluded medication within 7 days prior to Visit 2. [23] Have been treated with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of Visit 2 or potentially need to use an MAOI during the study or within 5 days of discontinuation of study drug. [24] Exhibit a lack of response of the current episode of GAD to 2 or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks. [25] Have a history of severe allergies, hypersensitivity to duloxetine or to any of the inactive ingredients; multiple adverse drug reactions; transcranial magnetic stimulation (TMS); history of seizures; or history of psychosurgery or electroconvulsive therapy (ECT) within 12 months. [26] Have discontinued hormone replacement therapy within the previous 3 months. [29] Have uncontrolled narrow-angle glaucoma. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement from base line to visit 6 in anxiety symptoms as measured by the HAMA total score. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
|
Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |