Separation Anxiety Disorder
Conditions
Keywords
Adult separation anxiety disorder, ASAD
Brief summary
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.
Detailed description
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.
Interventions
DRUGVilazodone
10mg to 40mg per day for 12 weeks
DRUGPlacebo
One to two pills per day for 12 weeks
Sponsors
Forest Laboratories
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Current primary (most clinically significant) diagnosis of DSM5 ASAD * Able to give consent, fluent in English
Exclusion criteria
* Past or current DSM-IV diagnosis of any psychotic disorder; organic mental disorder or other cognitive disorder; bipolar disorder; or antisocial personality disorder. Current MDD of moderate or greater severity. Any other current primary Axis I disorder. * Recent history (past 3 months) of substance or alcohol abuse or dependence (other than nicotine or caffeine) * Suicidal ideation or behavior (in the past year) that poses a significant danger to the subject * Medical illness that could significantly increase risk of vilazodone treatment or interfere with assessment of diagnosis or treatment response, including organic brain impairment from stroke, CNS tumor, or demyelinating disease; renal impairment; diabetes mellitus * Current or past history of seizure disorder (except febrile seizure in childhood) * History of non-response to ≥ 2 serotonergic reuptake inhibitor antidepressants (SSRIs and/or SNRIs) for the treatment of ASAD after adequate treatment trials (adequate treatment is defined as at least 8 weeks at an adequate dose\[s\] based on approved package insert recommendations) * Currently taking medication which has been effective for patient's ASAD * For patients taking any ineffective psychoactive drug or herbal remedy, inability to tolerate or unwillingness to accept a drug-free period prior to beginning the study of 2 weeks or 5 half-lives (whichever is longer) before beginning study treatment, or ever having been treated with a depot antipsychotic. Fluoxetine washout period will be at least 5 weeks. * Requiring concomitant treatment with any prohibited medications, supplements, or herbal remedies, except for zolpidem, or zolpidem extended release for insomnia, which may be continued provided the medication has been used in a consistent manner for 4 weeks prior to randomization * History of intolerance or hypersensitivity to vilazodone, SNRIs or SSRIs * History of light therapy, electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation, or any other experimental procedure for central nervous system disorders within 6 months of beginning this study * Pregnancy, lactation; for women of childbearing potential, not using an effective birth control method (e.g., oral contraceptive or double barrier method) for the duration of the study * Current formal psychotherapy initiated within 3 months of beginning this study. This includes: psychodynamic, cognitive-behavioral and interpersonal therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement Scale | Up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score | Up to 12 weeks | 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). |
| Change From Baseline in Attachment Style Questionnaire Score | Up to 12 weeks | 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). |
| Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire | Up to 12 weeks | 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. |
| Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder | Baseline and week 12 | 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). |
| Change From Baseline on Adult Separation Anxiety - 27 Scale | Up to 12 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Placebo Pill placebo.
Placebo: One to two pills per day for 12 weeks | 11 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Vilazodone | Placebo |
|---|---|---|---|
| Adult Separation Anxiety - 27 Scale | 47.8 units on a scale STANDARD_DEVIATION 14.7 | 44.3 units on a scale STANDARD_DEVIATION 15.1 | 52.0 units on a scale STANDARD_DEVIATION 13.6 |
| Age, Continuous | 35.2 Years STANDARD_DEVIATION 14.7 | 37.3 Years STANDARD_DEVIATION 14.2 | 32.9 Years STANDARD_DEVIATION 15.6 |
| Attachment Style Questionnaire Confidence | 28.1 units on a scale STANDARD_DEVIATION 7.7 | 30.5 units on a scale STANDARD_DEVIATION 5.3 | 25.3 units on a scale STANDARD_DEVIATION 9.3 |
| Attachment Style Questionnaire Discomfort with Closeness | 42.2 units on a scale STANDARD_DEVIATION 9.3 | 38.2 units on a scale STANDARD_DEVIATION 8.9 | 46.9 units on a scale STANDARD_DEVIATION 7.7 |
| Attachment Style Questionnaire Need for Approval | 24.8 units on a scale STANDARD_DEVIATION 6.8 | 23.8 units on a scale STANDARD_DEVIATION 4.6 | 26.1 units on a scale STANDARD_DEVIATION 8.8 |
| Attachment Style Questionnaire Preoccupation with Relationships | 34.0 units on a scale STANDARD_DEVIATION 5.6 | 34.4 units on a scale STANDARD_DEVIATION 5.1 | 33.6 units on a scale STANDARD_DEVIATION 6.3 |
| Attachment Style Questionnaire Relationships as Secondary | 18.1 units on a scale STANDARD_DEVIATION 5.9 | 17.4 units on a scale STANDARD_DEVIATION 6 | 19.0 units on a scale STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Depression Rating Scale 17-item | 10.5 units on a scale STANDARD_DEVIATION 5.7 | 11.5 units on a scale STANDARD_DEVIATION 6.3 | 9.3 units on a scale STANDARD_DEVIATION 5 |
| Quality of Life Enjoyment & Satisfaction Questionnaire | 50.6 units on a scale STANDARD_DEVIATION 17.7 | 46.5 units on a scale STANDARD_DEVIATION 12.1 | 55.4 units on a scale STANDARD_DEVIATION 22.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 3 Participants |
| Structured Clinical Interview for Separation Anxiety Disorder | 10.5 units on a scale STANDARD_DEVIATION 2.5 | 10.8 units on a scale STANDARD_DEVIATION 2.6 | 10.2 units on a scale STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 13 / 13 | 11 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vilazodone | Clinical Global Impression-Improvement Scale | 7 Participants |
| Placebo | Clinical Global Impression-Improvement Scale | 4 Participants |
p-value: 0.064Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilazodone | Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score | 3.7 units on a scale | Standard Deviation 3.2 |
| Placebo | Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score | 8.4 units on a scale | Standard Deviation 7.2 |
p-value: 0.1195% CI: [-1.32, 12.32]Mixed Models Analysis
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vilazodone | Change From Baseline in Attachment Style Questionnaire Score | Confidence | 32.3 units on a scale | Standard Deviation 7.3 |
| Vilazodone | Change From Baseline in Attachment Style Questionnaire Score | Relationships as Secondary | 16.3 units on a scale | Standard Deviation 4.3 |
| Vilazodone | Change From Baseline in Attachment Style Questionnaire Score | Preoccupation with Relationships | 30.0 units on a scale | Standard Deviation 6 |
| Vilazodone | Change From Baseline in Attachment Style Questionnaire Score | Need for Approval | 20.6 units on a scale | Standard Deviation 3.2 |
| Vilazodone | Change From Baseline in Attachment Style Questionnaire Score | Discomfort with Closeness | 35.6 units on a scale | Standard Deviation 5.9 |
| Placebo | Change From Baseline in Attachment Style Questionnaire Score | Preoccupation with Relationships | 32.1 units on a scale | Standard Deviation 7.8 |
| Placebo | Change From Baseline in Attachment Style Questionnaire Score | Confidence | 26.9 units on a scale | Standard Deviation 10.3 |
| Placebo | Change From Baseline in Attachment Style Questionnaire Score | Discomfort with Closeness | 42.3 units on a scale | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Attachment Style Questionnaire Score | Relationships as Secondary | 20.7 units on a scale | Standard Deviation 9.1 |
| Placebo | Change From Baseline in Attachment Style Questionnaire Score | Need for Approval | 23.6 units on a scale | Standard Deviation 8 |
Comparison: Confidence variablep-value: 0.8995% CI: [-4.85, 5.53]Mixed Models Analysis
Comparison: Discomfort with Closeness variablep-value: 0.7995% CI: [-8.21, 10.58]Mixed Models Analysis
Comparison: Relationships as Secondary variablep-value: 0.3195% CI: [-4.12, 12.01]Mixed Models Analysis
Comparison: Need for Approval variablep-value: 0.195% CI: [-5.79, 0.58]Mixed Models Analysis
Comparison: Preoccupation with Relationships variablep-value: 0.895% CI: [-5.3, 6.72]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilazodone | Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire | 68.9 units on a scale | Standard Deviation 9.8 |
| Placebo | Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire | 47.8 units on a scale | Standard Deviation 31 |
p-value: 0.00895% CI: [-34.23, -5.58]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilazodone | Change From Baseline on Adult Separation Anxiety - 27 Scale | 14.4 units on a scale | Standard Deviation 12.6 |
| Placebo | Change From Baseline on Adult Separation Anxiety - 27 Scale | 40.6 units on a scale | Standard Deviation 19.2 |
p-value: 0.0195% CI: [5.64, 37.11]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vilazodone | Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder | 3.1 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder | 5.0 units on a scale | Standard Deviation 3.5 |
p-value: 0.02695% CI: [0.42, 6.16]Mixed Models Analysis