Duloxetine 60 to 120 mg Once Daily Compared with Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-002626-22-DE
• Date of registration: 09/06/2005
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company Limited
• Public title: Duloxetine 60 to 120 mg Once Daily Compared with Placebo in the Prevention of Relapse in Generalized Anxiety Disorder
• Scientific title: Duloxetine 60 to 120 mg Once Daily Compared with Placebo in the Prevention of Relapse in Generalized Anxiety Disorder
• Date of first enrolment: 03/03/2005
• Target sample size: 760
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002626-22
• 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

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
(1)Male and female outpatients at least 18 years of age presenting with GAD absent of major depressive disorder based on the disease diagnostic criteria. Patients must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.

(2)Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) who are not breast-feeding; test negative for pregnancy at the time of enrollment based on a serum pregnancy test; and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control: diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 week following the last dose of study drug.

(3)Must have a Clinical Global Impressions of Severity (CGI-Severity) score >=4 at both Visit 1 and Visit 2.

(4) At Visit 1, patient must have a Covi Anxiety Scale (CAS) score >=9, no item on the Raskin Depression Scale (RDS) may be >3, and the CAS must be greater than the RDS.

(5) Must have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score >= 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) yes
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:
[6] Any current and primary DSM-IV-TR Axis I diagnosis other than GAD. Patients diagnosed with or who have a history of MDD within the past 6 months, or Patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (PTSD), or an eating disorder within
the past year, or Patients who have been diagnosed with obsessive-compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
[7] The presence of an Axis II disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
[8] Benzodiazepine use within 14 days prior to Visit 2.
[9] Taking any excluded medication within 7 days prior to Visit 2.
[10] Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of Visit 2 or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
[11] Lack of response of the current episode of GAD to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks.
[12] Patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion.
[13] Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
[14] Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine.
[15] History of alcohol or any psychoactive substance abuse or dependence
(as defined in the DSM-IV-TR) within the past 6 months.
[16] Excessive use of caffeine, in the opinion of the investigator. Note:
Tapering of caffeine-containing substances is permitted during the screening period as long as stabilization at a permitted level of use for 7 days (as determined by the investigator) has been established before Visit 2.
[17] A positive urine drug screen (UDS) for any substances of abuse at Visit 1. A retest may be performed if the UDS is positive for any prescribed substance. The results of the retest must be available prior to Visit 2.
[18] 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] Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
[20] Abnormal thyroid-stimulating hormone (TSH) concentrations (outside the reference range of the performing laboratory). Note: Patients previously diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate TSH concentrations, and are clinically euthyroid are allowed.
[21] Initiation of psychotherapy, change in 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] History of severe allergies, hypersen

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

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder

Intervention(s)

Product Name: duloxetine hydrochloride
Product Code: LY248686
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Duloxetine
CAS Number: 136434-34-9
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Secondary gatekeeper objective is to evaluate the efficacy of duloxetine 60 to 120 mg QD compared with placebo as measured by the mean change on the Sheehan Disability Scale Global Functional Impairment score. Additional secondary objectives:
Open-Label Acute Therapy Phase: To assess the efficacy and safety of duloxetine using the efficacy and safety measures completed during this phase. Double-Blind Continuation Therapy Phase: To evaluate the efficacy of duloxetine as measured by the mean change on various measures (HAMA total score, Psychic Factor Score, Somatic Factor Score, anxious mood item, and tension item, …), and by relapse rates. To compare the effects of duloxetine on patients’ quality of life. To compare the safety and tolerability of duloxetine as measured by discontinuation rates, TEAEs, vital signs, weight, laboratory analyses. Taper/Follow-up Phase: To evaluate the effects of discontinuation of duloxetine treatment.

Main Objective: to assess the long-term maintenance of efficacy of duloxetine 60 to 120 mg once daily (QD) compared with placebo by a comparison of the time to relapse among patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revised (DSM-IV-TR)-defined generalized anxiety disorder (GAD) who responded to duloxetine during the open-label acute therapy phase after 22 to 26 weeks. Patients will be assessed for relapse during the 26- to 30-week double-blind continuation therapy phase.

Primary end point(s): The primary efficacy analysis is the time to relapse during the double-blind continuation therapy phase.

Secondary ID(s)

F1J-MC-HMDV(a)