Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183274

Purpose

This study will assess the effectiveness of venlafaxine XR in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.

Condition	Intervention	Phase
Anxiety Disorders	Drug: Venlafaxine XR Drug: Placebo	Phase IV

MedlinePlus related topics: Anxiety

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:

Short-Term Versus Long-Term Treatment in Generalized Anxiety Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Relapse of GAD [ Time Frame: Meausured at Months 6, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anxiety, depression, and GAD symptoms [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:

330

Study Start Date:

January 2004

Estimated Study Completion Date:

July 2009

Estimated Primary Completion Date:

July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Venlafaxine	Drug: Venlafaxine XR All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine.
2: Experimental Venlafaxine and placebo	Drug: Venlafaxine XR All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine. Drug: Placebo After initial treatment with venlafaxine, some participants will be randomized to take placebo for 6 months in the second phase of the study and then to switch back to venlafaxine or continue with placebo for an additional 6 months.

Arms

Assigned Interventions

1: Experimental

Venlafaxine

Drug: Venlafaxine XR

All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine.

2: Experimental

Venlafaxine and placebo

Drug: Venlafaxine XR

All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine.

Drug: Placebo

After initial treatment with venlafaxine, some participants will be randomized to take placebo for 6 months in the second phase of the study and then to switch back to venlafaxine or continue with placebo for an additional 6 months.

Detailed Description:

Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.

Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

GAD diagnosis by structured interview
Hamilton Anxiety Scale score of 18 or less
Clinical Global Impressions Scale score of at least 4
Hamilton Depression Scale score of 18 or less
Hamilton Depression Scale suicide item score less than 2
Use of an effective form of contraception throughout the study

Exclusion Criteria:

Hypersensitivity to venlafaxine XR
History of seizures
Episode of major depressive disorder in the previous 6 months
History of any psychotic illness, bipolar disorder, or dementia
Substance abuse and dependence during the past 6 months
Other anxiety disorders with the exception of social phobia as long as GAD is primary
Regular use of anxiolytics or antidepressants within 7 days of study onset
Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
Use of other psychotic medication besides benzodiazepines during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183274

Contacts

Contact: Karl Rickels, MD

215-746-6417

krickels@mail.med.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania, 3535 Market Street, Suite 670	Recruiting
Philadelphia, Pennsylvania, United States, 19104-3309
Contact: Karl Rickels, MD 215-746-6417 krickels@mail.med.upenn.edu
Contact: Bijan Etemad, MD 215-898-4301 betemad@mail.med.upenn.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Karl Rickels, MD

University of Pennsylvania

More Information

Responsible Party:

University of Pennsylvania ( Karl Rickels, MD )

Study ID Numbers:

R01 MH65963, DSIR 83-ATAS

First Received:

September 12, 2005

Last Updated:

September 2, 2008

ClinicalTrials.gov Identifier:

NCT00183274

Health Authority:

United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Generalized Anxiety Disorder
Chronic Mediation Treatment
Double-Blind

Placebo Controlled
Venlafaxine XR
Relapse

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Venlafaxine
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 07, 2009