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

• Register: EUCTR
• Last refreshed on: 18 September 2012
• Main ID: EUCTR2009-010902-13-AT
• Date of registration: 20/07/2010
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Duloxetine versus Placebo in the Treatment of Elderly Patients with Generalized Anxiety Disorder - HMGF
• Scientific title: Duloxetine versus Placebo in the Treatment of Elderly Patients with Generalized Anxiety Disorder - HMGF
• Date of first enrolment: 08/09/2010
• Target sample size: 288
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010902-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Germany, Spain, United Kingdom

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Generalized anxiety disorder (GAD)
MedDRA version: 12.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder

Intervention(s)

Trade Name: Cymbalta 30 mg hard gastro-resistant capsules
Product Name: Duloxetine
Product Code: LY248686
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Duloxetine
CAS Number: 136434-34-9
Current Sponsor code: LY248686
Other descriptive name: Duloxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Cymbalta 60 mg hard gastro-resistant capsules
Product Name: Duloxetine
Product Code: LY248686
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Duloxetine
CAS Number: 136434-34-9
Current Sponsor code: LY248686
Other descriptive name: Duloxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Improvement from base line to visit 6 in anxiety symptoms as measured by the HAMA total score.

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:
- 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.

Secondary ID(s)

2009-010902-13-ES

F1J-MC-HMGF(a)