Study Of Generalized Anxiety Disorder

NCT00135525 | Completed Phase 2

• 1 other identifier: BRL29060A/856
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients

Conditions

Anxiety Disorder; Anxiety Disorders

Keywords

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])

  8 Weeks

Secondary Outcomes (1)

• Mean change from baseline in the HAM-A score (at Weeks 1, 2, 4 and 6); in the Severity of Illness (CGI SI) score; in the SDS and MADRS total scoreProportion of responders based on the Clinical Global Impression Global Improvement (CGI GI) score

  8 Weeks

Study Arms (2)

Paroxetine

EXPERIMENTAL

Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries. Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan.

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paroxetine DRUG

Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries. Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan.

Paroxetine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Generalized Anxiety Disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
• Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.

You may not qualify if:

• Have the following conditions currently or diagnosed in the past 24 weeks:
• Major Depressive Episode, Panic Disorder Without Agoraphobia, Panic Disorder With Agoraphobia, Social phobia/social anxiety disorder (SAD), Agoraphobia Without History of Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Dysthymic disorder
• Current or history of schizophrenia, bipolar disorder or cyclothymic disorder.
• Psychotherapy or cognitive behavioral therapy other than supportive psychotherapy.
• Current or history of substance abuse (alcohol or drugs) or substance in past 24 weeks.
• Taken St. John's Wort in past 4 weeks.
• Had electroconvulsive therapy (ECT) in past 12 weeks.
• Had psychotherapy or cognitive behavioral therapy other than supportive psychotherapy within 24 weeks.
• Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy by 30 days after the completion of final dose.
• Pose a suicidal threat or have attempted suicide in past 24 weeks.
• History of convulsive disorder (epilepsy, etc.).
• Significant unstable medical illness.
• Current or history of glaucoma.
• History or complication of cancer or malignant tumor.
• History of hypersensitivity to paroxetine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 26, 2005
• Study Start: May 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: May 1, 2006
• Last Updated: January 31, 2011

Record last verified: 2011-01