A Study of Duloxetine in Elderly Generalized Anxiety Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01118780
• Date of registration: 05/05/2010
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Duloxetine in Elderly Generalized Anxiety Disorder
• Scientific title: Duloxetine Versus Placebo in the Treatment of Elderly Patients With Generalized Anxiety Disorder
• Date of first enrolment: October 2010
• Target sample size: 288
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01118780
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

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

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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 score of greater than or equal to 9, no item in the Raskin
Depression Scale (CAS)may be >3, and the Covi Anxiety Scale score must be greater
than the Raskin Depression Scale (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 patient 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 DSM-IV TR Axis I diagnosis other than GAD, with the
exception of comorbid social phobia or specific phobia.

- (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 patients
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 patients 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 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.



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder

Intervention(s)

Drug: Duloxetine

Drug: Placebo

Primary Outcome(s)

Change from baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) total score [Time Frame: Baseline, 10 weeks]

Secondary Outcome(s)

Adverse events leading to discontinuation from study [Time Frame: 10 weeks]

Change from baseline to Week 10 endpoint in Hospital Anxiety Depression Scale (HADS) subscale scores [Time Frame: Baseline, 10 weeks]

Change from baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) pain severity and interference subscales [Time Frame: Baseline, 10 weeks]

Change from baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor score, Somatic Anxiety Factor Score, and individual item scores: anxious mood item and tension item) [Time Frame: Baseline, 10 weeks]

Change from baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score [Time Frame: Baseline, 10 weeks]

Change from baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score [Time Frame: Baseline, 10 weeks]

Change from baseline to Week 10 in Sheehan Disability Scale (SDS) work/school, social life, and family/home management individual impairment scores [Time Frame: Baseline, 10 weeks]

Clinical Global Impressions of Improvement scale (CGI-Improvement) at Week 10 [Time Frame: 10 weeks]

Functional Remission rate at Week 10 [Time Frame: 10 Weeks]

Patient's Global Impressions of Improvement scale (PGI-Improvement) at Week 10 [Time Frame: 10 weeks]

Proportion of patients reporting falling down [Time Frame: Baseline through 10 weeks]

Response and Remission rates at Week 10 [Time Frame: 10 Weeks]

Sustained Improvement rate at Week 10 [Time Frame: 10 Weeks]

The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: Baseline through 10 weeks]

Secondary ID(s)

12866

F1J-MC-HMGF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors