Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Karl Rickels, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00183274
First received: September 12, 2005
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Versus Long-term Treatment in Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hamilton Rating Scale for Anxiety [ Time Frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse) ] [ Designated as safety issue: No ]

    Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating

    Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.



Secondary Outcome Measures:
  • Clinical Global Impressions, Severity of Illness [ Time Frame: Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse) ] [ Designated as safety issue: No ]

    The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.

    The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

    Results of the "Placebo After Placebo" group in Phase 3 were not entered due to sample size limitations.



Enrollment: 268
Study Start Date: January 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open-Label Group
6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d
Drug: Venlafaxine XR
Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
Other Names:
  • selective serotonin and norepinephrine reuptake inhibitors
  • Effexor
  • Effexor XR
  • Venlafaxine hydrochloride extended release
  • Trevilor
  • Lanvexin
Active Comparator: Double-Blind Drug Group
6-month randomized, double-blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 6 - 12 of the study
Drug: Venlafaxine XR
Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
Other Names:
  • selective serotonin and norepinephrine reuptake inhibitors
  • Effexor
  • Effexor XR
  • Venlafaxine hydrochloride extended release
  • Trevilor
  • Lanvexin
Placebo Comparator: Double-Blind Placebo Group
6-month randomized, double blind phase of placebo occurring between months 6 - 12 of the study
Drug: Placebo
six month intervention with placebo drug
Active Comparator: Double-Blind Drug-After-Drug Group
6-month randomized, double blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 13 - 19 of the study
Drug: Venlafaxine XR
Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
Other Names:
  • selective serotonin and norepinephrine reuptake inhibitors
  • Effexor
  • Effexor XR
  • Venlafaxine hydrochloride extended release
  • Trevilor
  • Lanvexin
Placebo Comparator: Double-Blind Placebo-After-Drug Group
6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
Drug: Placebo
six month intervention with placebo drug
Placebo Comparator: Double-Blind Placebo-After-Placebo Group
6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
Drug: Placebo
six month intervention with placebo drug

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GAD diagnosis by structured interview
  • Hamilton Anxiety Scale score of 18 or MORE
  • Clinical Global Impressions Severity 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 psychotropic medication besides benzodiazepines during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pennsylvania, 3535 Market Street, Suite 670
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Karl Rickels, MD University of Pennsylvania
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karl Rickels, Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00183274     History of Changes
Other Study ID Numbers: MH65963  R01MH065963 
Study First Received: September 12, 2005
Results First Received: December 14, 2012
Last Updated: October 6, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Generalized Anxiety Disorder
Chronic Mediation Treatment
Double-Blind
Placebo Controlled
Venlafaxine XR
Relapse

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Serotonin and Noradrenaline Reuptake Inhibitors
Venlafaxine Hydrochloride
Norepinephrine
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on December 09, 2016