Trial Outcomes & Findings for Vilazodone for Separation Anxiety Disorder (NCT NCT01999920)
NCT ID: NCT01999920
Last Updated: 2018-03-07
Results Overview
Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
Vilazodone
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vilazodone for Separation Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
32.9 Years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
35.2 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 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
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Hamilton Depression Rating Scale 17-item
|
11.5 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 5.0 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Attachment Style Questionnaire
Confidence
|
30.5 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 9.3 • n=7 Participants
|
28.1 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Attachment Style Questionnaire
Discomfort with Closeness
|
38.2 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
46.9 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
42.2 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Attachment Style Questionnaire
Relationships as Secondary
|
17.4 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
|
19.0 units on a scale
STANDARD_DEVIATION 5.9 • n=7 Participants
|
18.1 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Attachment Style Questionnaire
Need for Approval
|
23.8 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 8.8 • n=7 Participants
|
24.8 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Attachment Style Questionnaire
Preoccupation with Relationships
|
34.4 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
33.6 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Quality of Life Enjoyment & Satisfaction Questionnaire
|
46.5 units on a scale
STANDARD_DEVIATION 12.1 • n=5 Participants
|
55.4 units on a scale
STANDARD_DEVIATION 22.2 • n=7 Participants
|
50.6 units on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Structured Clinical Interview for Separation Anxiety Disorder
|
10.8 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Adult Separation Anxiety - 27 Scale
|
44.3 units on a scale
STANDARD_DEVIATION 15.1 • n=5 Participants
|
52.0 units on a scale
STANDARD_DEVIATION 13.6 • n=7 Participants
|
47.8 units on a scale
STANDARD_DEVIATION 14.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksClinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Clinical Global Impression-Improvement Scale
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksThis standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score
|
3.7 units on a scale
Standard Deviation 3.2
|
8.4 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Up to 12 weeksMeasure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Attachment Style Questionnaire Score
Confidence
|
32.3 units on a scale
Standard Deviation 7.3
|
26.9 units on a scale
Standard Deviation 10.3
|
|
Change From Baseline in Attachment Style Questionnaire Score
Discomfort with Closeness
|
35.6 units on a scale
Standard Deviation 5.9
|
42.3 units on a scale
Standard Deviation 6.9
|
|
Change From Baseline in Attachment Style Questionnaire Score
Relationships as Secondary
|
16.3 units on a scale
Standard Deviation 4.3
|
20.7 units on a scale
Standard Deviation 9.1
|
|
Change From Baseline in Attachment Style Questionnaire Score
Need for Approval
|
20.6 units on a scale
Standard Deviation 3.2
|
23.6 units on a scale
Standard Deviation 8.0
|
|
Change From Baseline in Attachment Style Questionnaire Score
Preoccupation with Relationships
|
30.0 units on a scale
Standard Deviation 6.0
|
32.1 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Up to 12 weeksMeasure Description: (10 min) Quality of Life Enjoyment \& Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire
|
68.9 units on a scale
Standard Deviation 9.8
|
47.8 units on a scale
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Baseline and week 12The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16).
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder
|
3.1 units on a scale
Standard Deviation 2.4
|
5.0 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Up to 12 weeksMeasure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)
Outcome measures
| Measure |
Vilazodone
n=13 Participants
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 Participants
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Change From Baseline on Adult Separation Anxiety - 27 Scale
|
14.4 units on a scale
Standard Deviation 12.6
|
40.6 units on a scale
Standard Deviation 19.2
|
Adverse Events
Vilazodone
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vilazodone
n=13 participants at risk
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
Vilazodone: 10mg to 40mg per day for 12 weeks
|
Placebo
n=11 participants at risk
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
46.2%
6/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Heartburn
|
23.1%
3/13 • Baseline to week 12
|
9.1%
1/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Baseline to week 12
|
36.4%
4/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Decreased Appetite
|
30.8%
4/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Increased Appetite
|
46.2%
6/13 • Baseline to week 12
|
45.5%
5/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Dry Mouth
|
38.5%
5/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Gastrointestinal disorders
Diarrhea/Gas
|
30.8%
4/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Skin and subcutaneous tissue disorders
Excessive Sweating
|
15.4%
2/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Skin and subcutaneous tissue disorders
Skin Problems
|
7.7%
1/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Blood and lymphatic system disorders
Bruising Easily
|
0.00%
0/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Nervous system disorders
Restlessness
|
23.1%
3/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Nervous system disorders
Impaired Coordination
|
7.7%
1/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
General disorders
Insomnia
|
38.5%
5/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
General disorders
Fatigue
|
23.1%
3/13 • Baseline to week 12
|
45.5%
5/11 • Baseline to week 12
|
|
Nervous system disorders
Somnolence
|
15.4%
2/13 • Baseline to week 12
|
54.5%
6/11 • Baseline to week 12
|
|
Reproductive system and breast disorders
Decreased Libido (men)
|
15.4%
2/13 • Baseline to week 12
|
0.00%
0/11 • Baseline to week 12
|
|
Reproductive system and breast disorders
Decreased Libido (women)
|
7.7%
1/13 • Baseline to week 12
|
36.4%
4/11 • Baseline to week 12
|
|
Reproductive system and breast disorders
Sexual Dysfunction (men)
|
15.4%
2/13 • Baseline to week 12
|
0.00%
0/11 • Baseline to week 12
|
|
Reproductive system and breast disorders
Sexual Dysfunction (women)
|
30.8%
4/13 • Baseline to week 12
|
36.4%
4/11 • Baseline to week 12
|
|
Eye disorders
Blurry Vision
|
7.7%
1/13 • Baseline to week 12
|
45.5%
5/11 • Baseline to week 12
|
|
Nervous system disorders
Lightheadedness
|
46.2%
6/13 • Baseline to week 12
|
54.5%
6/11 • Baseline to week 12
|
|
Nervous system disorders
Forgetfulness
|
7.7%
1/13 • Baseline to week 12
|
18.2%
2/11 • Baseline to week 12
|
|
Nervous system disorders
Impaired Concentration
|
38.5%
5/13 • Baseline to week 12
|
45.5%
5/11 • Baseline to week 12
|
|
Nervous system disorders
Apathy
|
23.1%
3/13 • Baseline to week 12
|
27.3%
3/11 • Baseline to week 12
|
|
Nervous system disorders
Nervousness
|
7.7%
1/13 • Baseline to week 12
|
36.4%
4/11 • Baseline to week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place