A Study of Duloxetine in Elderly Generalized Anxiety Disorder

NCT ID: NCT01118780

Last Updated: 2013-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

Brief Summary

The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).

Conditions

Generalized Anxiety Disorder

Keywords

GAD; Generalized Anxiety Disorder; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine 30 milligrams (mg) -120 mg

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

Administered by mouth, daily for 10 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered by mouth, daily for 10 weeks

Interventions

Duloxetine

Administered by mouth, daily for 10 weeks

Intervention Type: DRUG

Placebo

Administered by mouth, daily for 10 weeks

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Duloxetine Hydrochloride; LY248686

Eligibility Criteria

Inclusion Criteria

• Have GAD based on diagnostic criteria and not suffer from an adjustment disorder or anxiety disorder not otherwise specified. Symptoms of GAD should not be situational in nature.
• Have a Mini Mental State Examination (MMSE) score of at least 24 at screening.
• Have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at screening and randomization.
• Have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be >3, and the CAS score must be greater than the RDS at screening.
• Have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at screening.
• Have a degree of understanding such that the participant can communicate intelligibly with the investigator and study coordinator.
• Are judged to be reliable to keep all appointments and able to swallow all required medication without opening or crushing.

Exclusion Criteria

• Have any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revised (DSM-IV TR) Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia.

• major depressive disorder (MDD) within the past 6 months, or
• panic disorder, posttraumatic stress disorder (PTSD), or an eating disorder within the past year, or
• obsessive compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
• The presence of an Axis II disorder, or history of antisocial behavior, or participants who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance.
• Have organic mental disorder or mental retardation diagnosis.
• Use of benzodiazepine within 14 days prior to randomization.
• Are judged clinically to be at serious risk of harm to self or others.
• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine within the past year or participants with a lack of response or intolerability to duloxetine (for any approved indication) at a clinically appropriate dose for a minimum of 4 weeks.
• Have a history of alcohol or any psychoactive substance abuse or dependence within the past 6 months.
• Excessively use caffeine, in the opinion of the investigator.
• Have a positive urine drug screen (UDS) for any substances of abuse at screening.
• Have a serious medical illness.
• Have any acute liver injury or severe cirrhosis.
• Have an abnormal thyroid-stimulating hormone (TSH) concentrations.
• 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.
• Have taken any excluded medication within 7 days prior to randomization.
• Have been treated with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of randomization or potentially need to use an MAOI during the study or within 5 days of discontinuation of study drug.
• 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.
• 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.
• Have discontinued hormone replacement therapy within the previous 3 months.
• Have uncontrolled narrow-angle glaucoma.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Orlando, Florida, United States

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Prairie Village, Kansas, United States

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Baltimore, Maryland, United States

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Nashua, New Hampshire, United States

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Toms River, New Jersey, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Clinton, Utah, United States

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Bellevue, Washington, United States

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Buenos Aires, , Argentina

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Rosario, , Argentina

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Santiago del Estero, , Argentina

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Vienna, , Austria

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Sydney, Nova Scotia, Canada

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Chatham, Ontario, Canada

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Berlin, , Germany

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Hattingen, , Germany

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Aguascalientes, , Mexico

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Monterrey, , Mexico

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Chełmno, , Poland

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Tuszyn, , Poland

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Bayamón, , Puerto Rico

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Ponce, , Puerto Rico

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Chesterfield, Chesterfield, United Kingdom

Countries

Spain; United States; Argentina; Austria; Canada; Germany; Mexico; Poland; Puerto Rico; United Kingdom

Other Identifiers

F1J-MC-HMGF

Identifier Type: OTHER

Identifier Source: secondary_id

12866

Identifier Type: -

Identifier Source: org_study_id