Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00149799
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Rhode Island Hospital (Other)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Duration (Months): 94
• Patients Per Site: 50
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study's primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders; Somatoform Disorders	Drug: Escitalopram; Drug: Placebo	Phase 3

Detailed Description

We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (BDD). BDD, an often-delusional preoccupation with a nonexistent or slight defect in appearance, is a distressing, impairing, and common body image disorder. It is associated with high rates of functional impairment and markedly poor quality of life. It appears that serotonin reuptake inhibitors (SRIs) are often--and selectively--efficacious for BDD and that many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious SRI at some point, as the alternative is life-long treatment. However, no relapse prevention studies have been done. Such a study is important from a clinical and public health perspective, because BDD appears to often be chronic and require long-term treatment. It is therefore critically important to investigate the risk of relapse with SRI discontinuation, and whether continuation SRI treatment decreases relapse risk.

Subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. Our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will explore 1) Whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e.g., quality of life) than those on placebo; 2) Change in symptoms with continuation of escitalopram during the continuation phase; and 3) Acute treatment response.

In summary, this study will be the first relapse prevention study in BDD and the first study of continuation pharmacotherapy in BDD. It will provide critically important information on relapse with continuation versus discontinuation of an SRI, whether continuation treatment protects against relapse, and change in symptoms with continuation treatment. This study will yield unique and clinically important data, and will fill gaps in knowledge about this common, severe, and understudied illness.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Escitalopram In Phase I, all participants received open-label escitalopram for 14 weeks (at a dosage of 10 mg/d in weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter). Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to continue with escitalopram for Phase II of the study (Weeks 16-40)	Drug: Escitalopram; At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.; Other Names: Lexapro
Placebo Comparator: Placebo Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to receive a placebo for Phase II of the study (Weeks 16-40)	Drug: Placebo; At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.

Outcome Measures

Primary Outcome Measures

1. Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS) [Phase II: Biweekly for six months after randomization]

   We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.

Secondary Outcome Measures

1. Phase I Response to Escitalopram (as Measured by the BDD-YBOCS) [Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14]

   We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.

2. Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II) [Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40]

   Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.

3. Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II) [Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)]

   Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.

4. Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II) [Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)]

   Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Outpatient men and women age 18 and older

• Diagnosis of BDD within 6 months of study start date based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

• Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale

• Lives within driving distance of Boston, MA or Providence, RI

Exclusion Criteria:

• Suicidal or homicidal tendencies

• Alcohol/drug abuse or dependence within 3 months of study entry

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Rhode Island Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute of Mental Health (NIMH)
• Rhode Island Hospital

Investigators

• Principal Investigator: Sabine Wilhelm, PhD, Massachusetts General Hospital (MGH)
• Principal Investigator: Katharine Phillips, MD, Rhode Island Hospital (RIH)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH

Publications

None provided.

• Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00149799
• Other Study ID Numbers: R01MH072854; R01MH072854; 2004-P-002305; DSIR 83-ATSO
• First Posted: Sep 8, 2005
• Last Update Posted: Dec 5, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Sabine Wilhelm, PhD, Massachusetts General Hospital: Body Dysmorphic Disorder; Escitalopram; Lexapro; BDD; Body Image
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Body Dysmorphic Disorders; Somatoform Disorders; Citalopram

Study Results

Participant Flow

Pre-assignment Detail	A total of 100 participants received open-label escitalopram in Phase I. Only those who completed Phase I, met criteria for response, and were willing to continue on in the study were subsequently randomized in Phase II (n=58).

Arm/Group Title	Phase I: Open-Label Escitalopram	Phase II: Double-blind Escitalopram	Phase II: Double-blind Placebo
Arm/Group Description	Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Period Title: Open Label Escitalopram (Phase I)
STARTED	100	0	0
COMPLETED	74	0	0
NOT COMPLETED	26	0	0
Period Title: Open Label Escitalopram (Phase I)
STARTED	0	28	30
COMPLETED	0	25	21
NOT COMPLETED	0	3	9

Baseline Characteristics

Arm/Group Title	Phase II: Escitalopram	Phase II: Placebo	Total
Arm/Group Description	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.	Total of all reporting groups
Overall Participants	28	30	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.3 (12.4)	31.8 (13.5)	33.5 (12.4)
Age (Count of Participants)
<=18 years	0 0%	1 3.3%	1 1.7%
Between 18 and 65 years	27 96.4%	28 93.3%	55 94.8%
>=65 years	1 3.6%	1 3.3%	2 3.4%
Sex: Female, Male (Count of Participants)
Female	20 71.4%	20 66.7%	40 69%
Male	8 28.6%	10 33.3%	18 31%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 3.3%	1 1.7%
Asian	1 3.6%	0 0%	1 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.6%	1 3.3%	2 3.4%
White	24 85.7%	27 90%	51 87.9%
More than one race	2 7.1%	1 3.3%	3 5.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 14.3%	5 16.7%	9 15.5%
Not Hispanic or Latino	24 85.7%	24 80%	48 82.8%
Unknown or Not Reported	0 0%	1 3.3%	1 1.7%
Region of Enrollment (participants) [Number]
United States	28 100%	30 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
Description	We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
Time Frame	Phase II: Biweekly for six months after randomization

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis of all 58 patients randomized to Phase II.

Arm/Group Title	Phase II: Escitalopram	Phase II: Placebo
Arm/Group Description	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Measure Participants	28	30
Number [percentage of subjects who relapsed]	18	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase II: Escitalopram, Phase II: Placebo
	Comments	Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Regression, Cox
	Comments	p-value is based on the likelihood ratio Chi-Square statistic.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.73
	Confidence Interval	(2-Sided) 95%; 1.01 to 8.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
Description	We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.
Time Frame	Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I: Open-Label Escitalopram
Arm/Group Description	Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
Measure Participants	100
Number [percentage of subjects who responded]	67

3. Secondary Outcome

Title	Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description	Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.
Time Frame	Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40

Outcome Measure Data

Analysis Population Description

A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.

Arm/Group Title	Phase II: Escitalopram	Phase II: Placebo
Arm/Group Description	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Measure Participants	28	30
Week 14	3.5357143 (4.4010280)	3.3793103 (3.3744184)
Week 16	3.8928571 (4.1840906)	4.2333333 (3.9799786)
Week 18	5.2857143 (5.5099717)	6.3703704 (6.4875511)
Week 20	4.8461538 (5.5403416)	5.4285714 (4.7798076)
Week 22	4.2307692 (3.5922995)	3.7407407 (3.0457106)
Week 24	3.625 (3.3337862)	3.7727273 (3.0539875)
Week 26	3.8695652 (4.0486176)	4.04 (3.8457769)
Week 28	4.48 (5.0259327)	4.4090909 (3.4731499)
Week 30	2.85 (3.9373381)	4.5454545 (4.0676104)
Week 32	2.9565217 (3.067102)	4.2 (4.007887)
Week 34	3.375 (3.2412088)	4.7 (4.5664682)
Week 36	4.0416667 (3.9943348)	5.4 (5.2555735)
Week 38	3.8181818 (3.8623502)	3.4666667 (3.8705235)
Week 40	4.2400000 (4.8500859)	4.1578947 (5.0250833)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase II: Escitalopram, Phase II: Placebo
	Comments	We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person. Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group [to be tested].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0930
	Comments	A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
	Method	Mixed Models Analysis
	Comments	Degrees of freedom=556
Method of Estimation	Estimation Parameter	Slope difference
	Estimated Value	-0.07006
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04163
	Estimation Comments

4. Secondary Outcome

Title	Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description	Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.
Time Frame	Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

Outcome Measure Data

Analysis Population Description

28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.

Arm/Group Title	Phase II: Escitalopram	Phase II: Placebo
Arm/Group Description	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Measure Participants	28	30
Week 14	9.0000000 (2.6943013)	8.2413793 (2.3551641)
Week 28	9.8000000 (3.3040379)	9.0000000 (2.7961012)
Week 40	9.7600000 (3.6887215)	8.8947368 (3.1428002)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase II: Escitalopram, Phase II: Placebo
	Comments	We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person. Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group [to be tested].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9766
	Comments	A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
	Method	Mixed Models Analysis
	Comments	Degrees of freedom=43
Method of Estimation	Estimation Parameter	Slope difference
	Estimated Value	0.001176
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03991
	Estimation Comments

5. Secondary Outcome

Title	Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description	Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.
Time Frame	Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

Outcome Measure Data

Analysis Population Description

28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.

Arm/Group Title	Phase II: Escitalopram	Phase II: Placebo
Arm/Group Description	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.	At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Measure Participants	28	30
Week 14	74.1785714 (12.9930282)	70.9259259 (16.0166402)
Week 28	70.2727273 (14.1528453)	67.3684211 (16.0665648)
Week 40	69.0833333 (18.5376624)	68.6470588 (15.2436100)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase II: Escitalopram, Phase II: Placebo
	Comments	We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person. Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group [to be tested].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7724
	Comments	A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
	Method	Mixed Models Analysis
	Comments	Degrees of freedom=36
Method of Estimation	Estimation Parameter	Slope difference
	Estimated Value	0.05723
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1963
	Estimation Comments

Adverse Events

Time Frame	Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
Arm/Group Title	Phase I: Open-Label Escitalopram		Phase II: Escitalopram		Phase II: Placebo
Arm/Group Description	Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.		At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.		At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
All Cause Mortality
	Phase I: Open-Label Escitalopram		Phase II: Escitalopram		Phase II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase I: Open-Label Escitalopram		Phase II: Escitalopram		Phase II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/28 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Phase I: Open-Label Escitalopram		Phase II: Escitalopram		Phase II: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/100 (89%)		22/28 (78.6%)		21/30 (70%)
Cardiac disorders
Heart Palpitations	2/100 (2%)	2	1/28 (3.6%)	2	2/30 (6.7%)	2
Endocrine disorders
Hot Flashes	0/100 (0%)	0	0/28 (0%)	0	2/30 (6.7%)	2
Gastrointestinal disorders
Nausea	36/100 (36%)	43	3/28 (10.7%)	4	4/30 (13.3%)	4
Flatulence	10/100 (10%)	10	2/28 (7.1%)	4	1/30 (3.3%)	1
Diarrhea	10/100 (10%)	11	5/28 (17.9%)	9	0/30 (0%)	0
Abdominal Pain	7/100 (7%)	7	2/28 (7.1%)	2	1/30 (3.3%)	1
Indigestion	4/100 (4%)	5	2/28 (7.1%)	2	0/30 (0%)	0
Vomiting	1/100 (1%)	1	2/28 (7.1%)	3	0/30 (0%)	0
General disorders
Fatigue	42/100 (42%)	55	6/28 (21.4%)	7	4/30 (13.3%)	4
Dry Mouth	28/100 (28%)	30	1/28 (3.6%)	1	3/30 (10%)	3
Headache	41/100 (41%)	58	9/28 (32.1%)	18	9/30 (30%)	16
Dizziness	6/100 (6%)	6	1/28 (3.6%)	1	6/30 (20%)	6
Sweating	8/100 (8%)	11	1/28 (3.6%)	1	1/30 (3.3%)	1
Vivid Dreams	5/100 (5%)	5	2/28 (7.1%)	2	0/30 (0%)	0
Yawning	5/100 (5%)	5	0/28 (0%)	0	2/30 (6.7%)	2
Restless Sleep / Not Insomnia	0/100 (0%)	0	0/28 (0%)	0	2/30 (6.7%)	2
Metabolism and nutrition disorders
Change in Appetite	23/100 (23%)	25	1/28 (3.6%)	1	3/30 (10%)	3
Musculoskeletal and connective tissue disorders
Back Pain	2/100 (2%)	2	0/28 (0%)	0	2/30 (6.7%)	2
Psychiatric disorders
Insomnia	34/100 (34%)	37	3/28 (10.7%)	4	7/30 (23.3%)	7
Agitation	12/100 (12%)	13	0/28 (0%)	0	1/30 (3.3%)	2
Irritability	6/100 (6%)	6	2/28 (7.1%)	2	4/30 (13.3%)	4
Somnolence	8/100 (8%)	9	0/28 (0%)	0	1/30 (3.3%)	1
Anxiety	6/100 (6%)	9	1/28 (3.6%)	1	2/30 (6.7%)	2
Reproductive system and breast disorders
Sexual Dysfunction	31/100 (31%)	33	2/28 (7.1%)	2	1/30 (3.3%)	1
Menstrual Cramps	3/100 (3%)	4	2/28 (7.1%)	2	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Cold Symptoms	7/100 (7%)	10	4/28 (14.3%)	6	3/30 (10%)	4
Rhinitis	1/100 (1%)	1	2/28 (7.1%)	2	0/30 (0%)	0
Upper Respiratory Infection	0/100 (0%)	0	2/28 (7.1%)	2	0/30 (0%)	0
Skin and subcutaneous tissue disorders
Poison Ivy	0/100 (0%)	0	0/28 (0%)	0	2/30 (6.7%)	2

Limitations/Caveats

Our findings may not be fully generalizable - for example, we excluded those with a co-occurring substance use disorder, higher levels of suicidality, and more severely ill patients who required concomitant therapy or a higher level of care.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.