Duloxetine versus Placebo in the Treatment of Elderly Patients with Generalized Anxiety Disorder - HMGF

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 288

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: Efficacy, including assessment of:<br>- Mean improvement on the Sheehan Disability Scale (SDS) Global Functional Impairment score.<br>- Response and remission rates<br>- Patients’ role functioning and quality of life<br><br>Safety and tolerability.;Primary end point(s): Improvement from base line to visit 6 in anxiety symptoms as measured by the HAMA total score.

Secondary Outcome Measures

Name	Time	Method

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