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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone | Experimental | 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. |
|
| Placebo | Placebo Comparator | Pill placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | 10mg to 40mg per day for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Schneier, MD | NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16741209 | Background | Shear K, Jin R, Ruscio AM, Walters EE, Kessler RC. Prevalence and correlates of estimated DSM-IV child and adult separation anxiety disorder in the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Jun;163(6):1074-83. doi: 10.1176/ajp.2006.163.6.1074. | |
| 1771219 | Background | Winslow JT, Insel TR. Serotonergic modulation of the rat pup ultrasonic isolation call: studies with 5HT1 and 5HT2 subtype-selective agonists and antagonists. Psychopharmacology (Berl). 1991;105(4):513-20. doi: 10.1007/BF02244372. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Pill placebo. Placebo: One to two pills per day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with adult separation anxiety disorder
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
Baseline to week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franklin Schneier, MD | NYSPI | 6464774-8041 | fschneier@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2016 | Aug 4, 2017 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2016 | Oct 3, 2017 | ICF_001.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 7, 2016 | Oct 3, 2017 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D001010 | Anxiety, Separation |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
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| Placebo | Drug | One to two pills per day for 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). |
| 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. | 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). | 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) | Up to 12 weeks |
| 17447222 | Background | Simpson BS, Landsberg GM, Reisner IR, Ciribassi JJ, Horwitz D, Houpt KA, Kroll TL, Luescher A, Moffat KS, Douglass G, Robertson-Plouch C, Veenhuizen MF, Zimmerman A, Clark TP. Effects of reconcile (fluoxetine) chewable tablets plus behavior management for canine separation anxiety. Vet Ther. 2007 Spring;8(1):18-31. |
| 18974308 | Background | Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30. |
| 11323729 | Background | Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703. |
| 29071764 | Derived | Schneier FR, Moskow DM, Choo TH, Galfalvy H, Campeas R, Sanchez-Lacay A. A randomized controlled pilot trial of vilazodone for adult separation anxiety disorder. Depress Anxiety. 2017 Dec;34(12):1085-1095. doi: 10.1002/da.22693. Epub 2017 Oct 25. |
| BG001 |
| Placebo |
Pill placebo. Placebo: One to two pills per day for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hamilton Depression Rating Scale 17-item | (10 min) Hamilton Rating Scale for Depression (Hamilton, 1960) This standard scale will be used to assess severity of depression, from 0 (least depression) to 50 (greatest depression | Mean | Standard Deviation | units on a scale |
|
| Attachment Style Questionnaire | (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) | Mean | Standard Deviation | units on a scale |
|
| Quality of Life Enjoyment & Satisfaction Questionnaire | (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. | Mean | Standard Deviation | units on a scale |
|
| Structured Clinical Interview for Separation Anxiety Disorder | Structured Clinical Interview for Separation Anxiety Disorder modified for DSM-5. The eight separation anxiety disorder criteria are each rated on a 0-2 scale for past week time frame. Scores on each of the eight items are summed to produce a total score (range 0 - 16). A higher total score indicates higher symptoms of separation anxiety. | Mean | Standard Deviation | units on a scale |
|
| Adult Separation Anxiety - 27 Scale | (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) | Mean | Standard Deviation | units on a scale |
|
Pill placebo.
Placebo: One to two pills per day for 12 weeks
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 12 weeks |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 12 weeks |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 12 |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Up to 12 weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Placebo | Pill placebo. Placebo: One to two pills per day for 12 weeks | 0 | 11 | 0 | 11 | 11 | 11 |
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea/Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Excessive Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising Easily | Blood and lymphatic system disorders | Systematic Assessment |
|
| Restlessness | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Impaired Coordination | Nervous system disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Decreased Libido (men) | Reproductive system and breast disorders | Systematic Assessment |
|
| Decreased Libido (women) | Reproductive system and breast disorders | Systematic Assessment |
|
| Sexual Dysfunction (men) | Reproductive system and breast disorders | Systematic Assessment |
|
| Sexual Dysfunction (women) | Reproductive system and breast disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Forgetfulness | Nervous system disorders | Systematic Assessment |
|
| Impaired Concentration | Nervous system disorders | Systematic Assessment |
|
| Apathy | Nervous system disorders | Systematic Assessment |
|
| Nervousness | Nervous system disorders | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
| Relationships as Secondary |
|
| Need for Approval |
|
| Preoccupation with Relationships |
|
| Mixed Models Analysis |
| 0.79 |
| Standard error |
| 1.18 |
| Standard Error of the Mean |
| 4.41 |
| 2-Sided |
| 95 |
| -8.21 |
| 10.58 |
| Superiority |
| Relationships as Secondary variable | Mixed Models Analysis | 0.31 | Standard error | 3.94 | Standard Error of the Mean | 3.79 | 2-Sided | 95 | -4.12 | 12.01 | Superiority |
| Need for Approval variable | Mixed Models Analysis | 0.10 | Standard error | -2.60 | Standard Error of the Mean | 1.49 | 2-Sided | 95 | -5.79 | 0.58 | Superiority |
| Preoccupation with Relationships variable | Mixed Models Analysis | 0.80 | Standard error | 0.71 | Standard Error of the Mean | 2.82 | 2-Sided | 95 | -5.30 | 6.72 | Superiority |