Phase 4
Completed N=268
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR
Source: ClinicalTrials.gov NCT00183274 ↗Enrolled (actual)
268
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Hamilton Rating Scale for Anxiety — 4.17; 6.29; 11.35; 5.80 HAM-A Rating Score
◆ Published Evidence
Established
62citations · ~4 / year
Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release.
Summary
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.
Linked Publications (5)
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Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release.
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Genetic polymorphisms in the PACAP and PAC1 receptor genes and treatment response to venlafaxine XR in generalized anxiety disorder.
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Genome-wide association study of treatment response to venlafaxine XR in generalized anxiety disorder.
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Lack of influence of DAT1 and DRD2 gene variants on antidepressant response in generalized anxiety disorder.
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Association analysis between the A118G polymorphism in the OPRM1 gene and treatment response to venlafaxine XR in generalized anxiety disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Anxiety |
4.17; 6.29; 11.35; 5.80; 8.42; 6.19 | — |
| SECONDARY Clinical Global Impressions, Severity of Illness |
1.37; 1.73; 2.64; 1.86; 2.25; 1.95 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00183274) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.