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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00183274
First Posted: September 16, 2005
Last Update Posted: January 16, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Karl Rickels, University of Pennsylvania
Results First Submitted: December 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety Disorders
Interventions: Drug: Venlafaxine XR
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Most patients (n=239) were recruited and seen by Penn research psychiatrists in 4 primary care practices; others (n=95) responded to media advertising (radio & print ads) at the central clinic at the University of Pennsylvania

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7-day washout period of any psychoactive medication;other antidepressants and herbal products. Subject on certain medications, such as monamine oxidase inhibitor, investigational and antipsychotic drugs had to be off these medications for at least 30 days.

Reporting Groups
  Description
Phase 1: Open-Label Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
Phase 2: Double-Blind Venlafaxine XR Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
Phase 2: Double-Blind Placebo Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
Phase 3: Double-Blind Relapse Phase (Drug After Drug) Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
Phase 3: Double-Blind Relapse Phase (Placebo After Drug) Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
Phase 3: Double-Blind Relapse Phase (Placebo After Placebo) Patients administered placebo in Phase 2 continued to take placebo during Phase 3

Participant Flow for 3 periods

Period 1:   Phase 1: Open-Label
    Phase 1: Open-Label   Phase 2: Double-Blind Venlafaxine XR   Phase 2: Double-Blind Placebo   Phase 3: Double-Blind Relapse Phase (Drug After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)
STARTED   268   0   0   0   0   0 
COMPLETED   158 [1]   0   0   0   0   0 
NOT COMPLETED   110   0   0   0   0   0 
Adverse Event                31                0                0                0                0                0 
Lack of Efficacy                13                0                0                0                0                0 
Protocol Violation                11                0                0                0                0                0 
Withdrawal by Subject                13                0                0                0                0                0 
Lost to Follow-up                33                0                0                0                0                0 
Other                9                0                0                0                0                0 
[1] 110 dropouts during phase 1

Period 2:   Phase 2: Double-Blind
    Phase 1: Open-Label   Phase 2: Double-Blind Venlafaxine XR   Phase 2: Double-Blind Placebo   Phase 3: Double-Blind Relapse Phase (Drug After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)
STARTED   0 [1]   82 [2]   54 [2]   0   0   0 
COMPLETED   0   56 [3]   11 [4]   0   0   0 
NOT COMPLETED   0   26   43   0   0   0 
Relapsed                0                8                29                0                0                0 
Withdrawal by Subject                0                18                14                0                0                0 
[1] This phase ended after 6 months. There were no longer participants in this phase.
[2] 22 did not enter phase 2 due to lack of efficacy and withdrawal of consent
[3] 8 lost to relapse, 18 lost to dropout
[4] 29 lost to relapse, 14 lost to dropout

Period 3:   Phase 3: Double-Blind
    Phase 1: Open-Label   Phase 2: Double-Blind Venlafaxine XR   Phase 2: Double-Blind Placebo   Phase 3: Double-Blind Relapse Phase (Drug After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Drug)   Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)
STARTED   0   0 [1]   0 [1]   15 [2]   34 [2]   10 [2] 
COMPLETED   0   0   0   13 [3]   14 [4]   6 [5] 
NOT COMPLETED   0   0   0   2   20   4 
Withdrawal by Subject                0                0                0                1                9                2 
Relapsed                0                0                0                1                11                2 
[1] Phase 2 ended at the end of 12 months of study.
[2] 8 completed Phase 2 but did not enter phase 3
[3] 1 lost to relapse and 1 lost to dropout
[4] 11 lost to relapse and 9 lost to dropout
[5] 2 lost to relapse and 2 lost to dropout



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
334 participants were consented, but 64 withdrew consent and 2 deviated from protocol, resulting in 268 participants who entered the initial Phase 1.

Reporting Groups
  Description
Venlafaxine XR

Venlafaxine XR flexible dose of 75 - 225 mg/d

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.


Baseline Measures
   Venlafaxine XR 
Overall Participants Analyzed 
[Units: Participants]
 334 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      4   1.2% 
Between 18 and 65 years      280  83.8% 
>=65 years      50  15.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.11  (16.14) 
Gender 
[Units: Participants]
Count of Participants
 
Female      210  62.9% 
Male      124  37.1% 
Region of Enrollment 
[Units: Participants]
 
United States   334 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Rating Scale for Anxiety   [ Time Frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse) ]

2.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Increased attrition occurring as a function of trial length


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Karl Rickels, M.D.
Organization: UPENN
phone: 215-746-6417
e-mail: krickels@mail.med.upenn.edu


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


Responsible Party: Karl Rickels, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00183274     History of Changes
Other Study ID Numbers: MH65963
R01MH065963 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: December 14, 2012
Results First Posted: November 30, 2016
Last Update Posted: January 16, 2017



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