Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00183274 |
|
Recruitment Status :
Completed
First Posted : September 16, 2005
Results First Posted : November 30, 2016
Last Update Posted : January 16, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Disorders | Drug: Venlafaxine XR Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 268 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Short-term Versus Long-term Treatment in Generalized Anxiety Disorder |
| Study Start Date : | January 2004 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | September 2009 |
| Arm | Intervention/treatment |
|---|---|
|
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:
|
|
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:
|
|
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:
|
|
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 |
- Hamilton Rating Scale for Anxiety [ Time Frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse) ]
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.
- 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) ]
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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183274
| United States, Pennsylvania | |
| University of Pennsylvania, 3535 Market Street, Suite 670 | |
| Philadelphia, Pennsylvania, United States, 19104-3309 | |
| Principal Investigator: | Karl Rickels, MD | University of Pennsylvania |
Other 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 |
| Other Study ID Numbers: |
MH65963 R01MH065963 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 16, 2005 Key Record Dates |
| Results First Posted: | November 30, 2016 |
| Last Update Posted: | January 16, 2017 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
Generalized Anxiety Disorder Chronic Mediation Treatment Double-Blind |
Placebo Controlled Venlafaxine XR Relapse |
|
Disease Anxiety Disorders Pathologic Processes Mental Disorders Norepinephrine Venlafaxine Hydrochloride Serotonin Serotonin and Noradrenaline Reuptake Inhibitors Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Vasoconstrictor Agents Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Receptor Agonists Serotonin Agents |