Trial Outcomes & Findings for Combined Treatment for Generalized Anxiety Disorder (GAD) (NCT NCT00620776)
NCT ID: NCT00620776
Last Updated: 2017-02-16
Results Overview
The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; 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 and 25-30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Results posted on
2017-02-16
Participant Flow
Three hundred thirty four patients enrolled in the first phase (6-month open-label) of a parent medication trial for GAD (NCT00183274) were recruited and seen in one of four primary care practices or a psychopharmacology clinic in a university setting from 2005 to 2009. The current study was conducted from October, 2006 to March, 2008.
Of 334 patients who consented to the parent trial, 66 did not receive study drug (64 withdrew consent and 2 were protocol violators), leaving 268 who received at least one dose of open-label venlafaxine XR. For this study, 77 patients were randomly assigned to be offered CBT and 40 patients to not be offered CBT.
Participant milestones
| Measure |
Combined Treatment
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
40
|
|
Overall Study
Received at Least One Session/Dose
|
26
|
35
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Combined Treatment
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Overall Study
Did not receive treatment
|
3
|
5
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Combined Treatment for Generalized Anxiety Disorder (GAD)
Baseline characteristics by cohort
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 19.8 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Gender
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
35 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Population: Number analyzed at various time points differ due to patient dropout.
The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; 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 and 25-30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A)
Baseline
|
25.9 units on a scale
Standard Deviation 2.6
|
23.8 units on a scale
Standard Deviation 2.7
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 2
|
20.9 units on a scale
Standard Deviation 5.0
|
19.4 units on a scale
Standard Deviation 5.1
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 4
|
17.3 units on a scale
Standard Deviation 5.6
|
14.7 units on a scale
Standard Deviation 5.6
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 6
|
13.5 units on a scale
Standard Deviation 6.5
|
10.9 units on a scale
Standard Deviation 5.5
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 8
|
12.7 units on a scale
Standard Deviation 7.5
|
7.8 units on a scale
Standard Deviation 6.0
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 12
|
10.8 units on a scale
Standard Deviation 7.2
|
5.9 units on a scale
Standard Deviation 4.3
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 16
|
8.1 units on a scale
Standard Deviation 6.9
|
4.3 units on a scale
Standard Deviation 3.1
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 20
|
6.2 units on a scale
Standard Deviation 5.5
|
4.3 units on a scale
Standard Deviation 3.2
|
|
Hamilton Anxiety Rating Scale (HAM-A)
Week 24
|
6.5 units on a scale
Standard Deviation 5.4
|
3.4 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Population: Numbers analyzed at various time points differ due to patient dropout.
The HAD was used to assess patients' report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater anxiety.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Baseline
|
13.6 units on a scale
Standard Deviation 3.4
|
13.0 units on a scale
Standard Deviation 4.2
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 2
|
11.7 units on a scale
Standard Deviation 4.8
|
10.9 units on a scale
Standard Deviation 5.1
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 4
|
10.9 units on a scale
Standard Deviation 4.5
|
8.3 units on a scale
Standard Deviation 5.0
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 6
|
9.2 units on a scale
Standard Deviation 4.7
|
7.1 units on a scale
Standard Deviation 4.6
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 8
|
9.0 units on a scale
Standard Deviation 4.7
|
5.7 units on a scale
Standard Deviation 4.1
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 12
|
6.9 units on a scale
Standard Deviation 4.3
|
4.1 units on a scale
Standard Deviation 3.4
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 16
|
6.9 units on a scale
Standard Deviation 5.2
|
4.6 units on a scale
Standard Deviation 3.4
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 20
|
6.2 units on a scale
Standard Deviation 4.6
|
4.9 units on a scale
Standard Deviation 3.6
|
|
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Week 24
|
6.2 units on a scale
Standard Deviation 3.3
|
4.7 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Population: Numbers analyzed at various time points differ due to patient dropout.
The HAD was used to assess patients' report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater depression.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Baseline
|
9.8 units on a scale
Standard Deviation 5.7
|
7.3 units on a scale
Standard Deviation 3.4
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 2
|
8.5 units on a scale
Standard Deviation 5.1
|
6.8 units on a scale
Standard Deviation 3.9
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 4
|
7.9 units on a scale
Standard Deviation 5.1
|
5.3 units on a scale
Standard Deviation 3.8
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 6
|
6.3 units on a scale
Standard Deviation 5.0
|
4.5 units on a scale
Standard Deviation 3.3
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 8
|
7.0 units on a scale
Standard Deviation 5.3
|
3.4 units on a scale
Standard Deviation 3.3
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 12
|
5.5 units on a scale
Standard Deviation 4.6
|
2.9 units on a scale
Standard Deviation 2.7
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 16
|
5.6 units on a scale
Standard Deviation 4.9
|
2.0 units on a scale
Standard Deviation 2.3
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 20
|
4.3 units on a scale
Standard Deviation 4.3
|
2.1 units on a scale
Standard Deviation 2.3
|
|
Hospital Anxiety Depression Scale (HAD)-Depression Score
Week 24
|
4.7 units on a scale
Standard Deviation 3.9
|
2.9 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Population: Numbers analyzed at various time points differ due to patient dropout.
The 17-item version of the HAM-D was used to assess severity of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50. A higher scores indicates greater depression. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D)-17-item Score
Baseline
|
13.1 units on a scale
Standard Deviation 2.2
|
12.3 units on a scale
Standard Deviation 2.8
|
|
Hamilton Rating Scale for Depression (HAM-D)-17-item Score
Week 12
|
7.0 units on a scale
Standard Deviation 3.4
|
3.9 units on a scale
Standard Deviation 2.6
|
|
Hamilton Rating Scale for Depression (HAM-D)-17-item Score
Week 24
|
5.1 units on a scale
Standard Deviation 4.0
|
3.0 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Population: Number analyzed at each time point differs due to patient dropout.
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Clinical Global Impression (CGI)-Severity Score
Baseline
|
4.7 units on a scale
Standard Deviation 0.6
|
4.7 units on a scale
Standard Deviation 0.5
|
|
Clinical Global Impression (CGI)-Severity Score
Week 2
|
4.1 units on a scale
Standard Deviation 0.6
|
3.9 units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression (CGI)-Severity Score
Week 4
|
3.6 units on a scale
Standard Deviation 0.8
|
3.2 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression (CGI)-Severity Score
Week 6
|
3.0 units on a scale
Standard Deviation 1.0
|
2.6 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression (CGI)-Severity Score
Week 8
|
2.9 units on a scale
Standard Deviation 1.3
|
1.9 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression (CGI)-Severity Score
Week 12
|
2.4 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression (CGI)-Severity Score
Week 16
|
2.1 units on a scale
Standard Deviation 1.1
|
1.4 units on a scale
Standard Deviation 0.6
|
|
Clinical Global Impression (CGI)-Severity Score
Week 20
|
1.7 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.6
|
|
Clinical Global Impression (CGI)-Severity Score
Week 24
|
1.8 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Population: Number analyzed at different time points varies due to patient dropout.
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Clinical Global Impression (CGI)-Improvement Score
Baseline
|
2.6 units on a scale
Standard Deviation 1.9
|
3.1 units on a scale
Standard Deviation 1.7
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 2
|
3.3 units on a scale
Standard Deviation 0.7
|
3.2 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 4
|
2.7 units on a scale
Standard Deviation 0.9
|
2.4 units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 6
|
2.4 units on a scale
Standard Deviation 0.9
|
2.0 units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 8
|
2.3 units on a scale
Standard Deviation 1.2
|
1.5 units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 12
|
1.9 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 0.6
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 16
|
1.6 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 0.4
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 20
|
1.4 units on a scale
Standard Deviation 0.7
|
1.2 units on a scale
Standard Deviation 0.4
|
|
Clinical Global Impression (CGI)-Improvement Score
Week 24
|
1.4 units on a scale
Standard Deviation 0.6
|
1.1 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Population: Number analyzed at different time points varies due to patient dropout.
The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire. Scores on the 12 items were added up to create summary score (range = 0 to 36). Higher scores indicate worse health.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Quality of Life Subscale of the General Health Questionnaire (GHQ)
Baseline
|
34.5 units on a scale
Standard Deviation 7.0
|
32.2 units on a scale
Standard Deviation 6.4
|
|
Quality of Life Subscale of the General Health Questionnaire (GHQ)
Week 12
|
24.8 units on a scale
Standard Deviation 7.3
|
20.4 units on a scale
Standard Deviation 5.2
|
|
Quality of Life Subscale of the General Health Questionnaire (GHQ)
Week 24
|
23.8 units on a scale
Standard Deviation 6.6
|
22.9 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Population: Number analyzed at different time points varies due to patient dropout.
The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Penn State Worry Questionnaire (PSWQ)
Baseline
|
61.8 units on a scale
Standard Deviation 9.5
|
57.9 units on a scale
Standard Deviation 12.7
|
|
Penn State Worry Questionnaire (PSWQ)
Week 12
|
48.6 units on a scale
Standard Deviation 11.8
|
42.3 units on a scale
Standard Deviation 13.0
|
|
Penn State Worry Questionnaire (PSWQ)
Week 24
|
46.4 units on a scale
Standard Deviation 11.1
|
45.1 units on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Population: Number analyzed at different time points varies due to patient dropout.
The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Physical Component Score of the 12-Item Short Form Survey (SF-12)
Baseline
|
46.1 units on a scale
Standard Deviation 13.6
|
52.7 units on a scale
Standard Deviation 10.7
|
|
Physical Component Score of the 12-Item Short Form Survey (SF-12)
Week 12
|
46.2 units on a scale
Standard Deviation 12.5
|
51.9 units on a scale
Standard Deviation 6.9
|
|
Physical Component Score of the 12-Item Short Form Survey (SF-12)
Week 24
|
45.5 units on a scale
Standard Deviation 12.7
|
49.7 units on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Population: Number analyzed at different time points varies due to patient dropout.
The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Mental Component Score of the 12-item Short Form Survey (SF-12)
Week 24
|
45.5 units on a scale
Standard Deviation 12.7
|
49.8 units on a scale
Standard Deviation 10.4
|
|
Mental Component Score of the 12-item Short Form Survey (SF-12)
Baseline
|
28.5 units on a scale
Standard Deviation 9.8
|
31.4 units on a scale
Standard Deviation 10.9
|
|
Mental Component Score of the 12-item Short Form Survey (SF-12)
Week 12
|
46.2 units on a scale
Standard Deviation 12.6
|
48.3 units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
Clinical Response Rate
|
17 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Data collected as part of protocol 709012 at baseline, week 12, and week 24Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9. This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample. The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula "c" for clinically significant change. This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population.
Outcome measures
| Measure |
Combined Treatment
n=26 Participants
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 Participants
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
50 Percent or Greater Reduction in PSWQ Score
|
19 Participants
|
28 Participants
|
Adverse Events
Combined Treatment
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Medication Alone
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Treatment
n=26 participants at risk
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 participants at risk
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
General disorders
Severe Fatigue
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
0.00%
0/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Severe Migraine
|
0.00%
0/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
0.00%
0/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Severe Constipation
|
0.00%
0/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Severe Impact on Libido
|
0.00%
0/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Skin and subcutaneous tissue disorders
Severe Rash
|
0.00%
0/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Eye disorders
Severe Vision Impairment
|
3.8%
1/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
0.00%
0/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
Other adverse events
| Measure |
Combined Treatment
n=26 participants at risk
Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
|
Medication Alone
n=35 participants at risk
Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
|
|---|---|---|
|
General disorders
Lightheadedness
|
23.1%
6/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
25.7%
9/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Nausea
|
26.9%
7/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
17.1%
6/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
8.6%
3/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Muscle Aches
|
19.2%
5/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
11.4%
4/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Psychiatric disorders
Insomnia
|
38.5%
10/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
17.1%
6/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Headache
|
34.6%
9/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
22.9%
8/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Faintness
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
8.6%
3/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Fatigue
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
8.6%
3/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Decreased Orgasm
|
11.5%
3/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
14.3%
5/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
14.3%
5/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Endocrine disorders
Increased Sweating
|
30.8%
8/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
22.9%
8/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Flatulence
|
19.2%
5/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
20.0%
7/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
4/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
17.1%
6/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Jittery
|
19.2%
5/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
25.7%
9/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Nightmares/Vivid Dreams
|
23.1%
6/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
11.4%
4/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Psychiatric disorders
Anorexia
|
3.8%
1/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
5.7%
2/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Anxiety
|
0.00%
0/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
5.7%
2/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Eye disorders
Blurred Vision
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Decreased Appetite
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Decreased Sex Drive
|
19.2%
5/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
14.3%
5/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Delayed Orgasm
|
7.7%
2/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Drowsiness
|
34.6%
9/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
37.1%
13/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Dry Mouth
|
30.8%
8/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
37.1%
13/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
Gastrointestinal disorders
Gas
|
15.4%
4/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
2.9%
1/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
|
General disorders
Tremors
|
3.8%
1/26 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
5.7%
2/35 • Over the 6-month study period, adverse events were assessed at each visit (from week 2 up to week 24) using an open-ended approach, which was facilitated by the use of a physician-completed medication problem checklist.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place