Duloxetine 60 to 120 mg Once Daily Compared withPlacebo in the Prevention of Relapse in GeneralizedAnxiety Disorder

Conditions: Generalized Anxiety Disorder

Registration Number: EUCTR2004-002626-22-DE

Lead Sponsor: Eli Lilly and Company Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 760

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