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Completed

NCT Number: NCT00803361

Duloxetine for the Treatment of Generalized Anxiety Disorder

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Psychiatric Diagnosis of generalized anxiety disorder (GAD)
  • Outpatients
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
  • Clinical Global Impression (CGI) of Severity Score of at least moderate
  • Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

Exclusion criteria

  • Pregnancy or breast feeding
  • Serious medical illness
  • Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
  • panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
  • lifetime history of bipolar or psychosis
  • Any unstable serious medical condition for which duloxetine would not be allowed
  • Any use of medications that are not allowed

Treatment and study plan

Duloxetine

Drug

60 to 120 mg, capsules, oral, once a day for 15 weeks

Other names: Cymbalta, LY248686

Placebo

Drug

placebo capsules, oral, once a day for 15 weeks

Primary outcomes

  1. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint

    Time frame: Baseline, Week 15

    A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Secondary outcomes

  1. Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint

    Time frame: Baseline, Week 15

    The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.

  2. Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint

    Time frame: Week 15

    Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).

  3. Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint

    Time frame: Baseline, Week 15

    BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

  4. Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores

    Time frame: Baseline, Week 15

    The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.

  5. Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint

    Time frame: Baseline, Week 15

    VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).

  6. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint

    Time frame: Baseline, Week 15

    A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2008
Registry last updated
Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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