A Phase 4 interventional study of Vilazodone and Placebo in Separation Anxiety Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week treatment course.
In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse events and safety.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 24 is below the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vilazodone
Pill placebo.
Drug: Placebo
10mg to 40mg per day for 12 weeks
Also known as: Viibryd (brand name)
One to two pills per day for 12 weeks
Clinical Global Impression-Improvement Scale
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.
Time frame: Up to 12 weeks
Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score
This 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).
Time frame: Up to 12 weeks
Change From Baseline in Attachment Style Questionnaire Score
Measure 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).
Time frame: Up to 12 weeks
Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire
Measure 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.
Time frame: Up to 12 weeks
Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder
The 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).
Time frame: Baseline and week 12
Change From Baseline on Adult Separation Anxiety - 27 Scale
Measure 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)
Time frame: Up to 12 weeks
| Milestone | Vilazodone | Placebo |
|---|---|---|
| Started | 13 | 11 |
| Completed | 7 | 9 |
| Not completed | 6 | 2 |
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.
| Participants | Vilazodone | Placebo |
|---|---|---|
| Clinical Global Impression-Improvement Scale | 7 | 4 |
This 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).
| units on a scale | Vilazodone | Placebo |
|---|---|---|
| Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score | 3.7 ± 3.2 | 8.4 ± 7.2 |
Measure 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).
| units on a scale | Vilazodone | Placebo |
|---|---|---|
| Confidence | 32.3 ± 7.3 | 26.9 ± 10.3 |
| Discomfort with Closeness | 35.6 ± 5.9 | 42.3 ± 6.9 |
| Relationships as Secondary | 16.3 ± 4.3 | 20.7 ± 9.1 |
| Need for Approval | 20.6 ± 3.2 | 23.6 ± 8.0 |
| Preoccupation with Relationships | 30.0 ± 6.0 | 32.1 ± 7.8 |
Measure 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.
| units on a scale | Vilazodone | Placebo |
|---|---|---|
| Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire | 68.9 ± 9.8 | 47.8 ± 31.0 |
The 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).
| units on a scale | Vilazodone | Placebo |
|---|---|---|
| Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder | 3.1 ± 2.4 | 5.0 ± 3.5 |
Measure 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)
| units on a scale | Vilazodone | Placebo |
|---|---|---|
| Change From Baseline on Adult Separation Anxiety - 27 Scale | 14.4 ± 12.6 | 40.6 ± 19.2 |
Collected over Baseline to week 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vilazodone | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Event | Vilazodone | Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 2/13 | 6/11 |
| LightheadednessNervous system disorders | 6/13 | 6/11 |
| HeadacheNervous system disorders | 6/13 | 3/11 |
| Increased AppetiteGastrointestinal disorders | 6/13 | 5/11 |
| FatigueGeneral disorders | 3/13 | 5/11 |
| Blurry VisionEye disorders | 1/13 | 5/11 |
| Impaired ConcentrationNervous system disorders | 5/13 | 5/11 |
| Dry MouthGastrointestinal disorders | 5/13 | 3/11 |
| InsomniaGeneral disorders | 5/13 | 3/11 |
| NauseaGastrointestinal disorders | 4/13 | 4/11 |
Subjects with adult separation anxiety disorder
| Age, Continuous(Years) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Mean | 37.3 ± 14.2 | 32.9 ± 15.6 | 35.2 ± 14.7 |
| Sex: Female, Male(Participants) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vilazodone | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 9 | 3 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Hamilton Depression Rating Scale 17-item(units on a scale) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Mean | 11.5 ± 6.3 | 9.3 ± 5.0 | 10.5 ± 5.7 |
| Attachment Style Questionnaire(units on a scale) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Confidence | 30.5 ± 5.3 | 25.3 ± 9.3 | 28.1 ± 7.7 |
| Discomfort with Closeness | 38.2 ± 8.9 | 46.9 ± 7.7 | 42.2 ± 9.3 |
| Relationships as Secondary | 17.4 ± 6.0 | 19.0 ± 5.9 | 18.1 ± 5.9 |
| Need for Approval | 23.8 ± 4.6 | 26.1 ± 8.8 | 24.8 ± 6.8 |
| Preoccupation with Relationships | 34.4 ± 5.1 | 33.6 ± 6.3 | 34.0 ± 5.6 |
| Quality of Life Enjoyment & Satisfaction Questionnaire(units on a scale) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Mean | 46.5 ± 12.1 | 55.4 ± 22.2 | 50.6 ± 17.7 |
| Structured Clinical Interview for Separation Anxiety Disorder(units on a scale) | Vilazodone | Placebo | Total |
|---|---|---|---|
| Mean | 10.8 ± 2.6 | 10.2 ± 2.5 | 10.5 ± 2.5 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Vilazodone
New York State Psychiatric Institute →