A Phase 3 interventional study of Escitalopram and Placebo in Anxiety Disorders and Somatoform Disorders, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-05.
Sponsored by Massachusetts General Hospital · Phase 3, Interventional, and Treatment
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.
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
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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.
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.
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
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 escitalopram (same dose as received in Phase I) for an additional 6 months.
Also known as: Lexapro
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.
Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
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
Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
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
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
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
Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
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)
Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
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)
| Milestone | Phase I: Open-Label Escitalopram | Phase II: Double-blind Escitalopram | Phase II: Double-blind Placebo |
|---|---|---|---|
| Started | 100 | 0 | 0 |
| Completed | 74 | 0 | 0 |
| Not completed | 26 | 0 | 0 |
| Milestone | Phase I: Open-Label Escitalopram | Phase II: Double-blind Escitalopram | Phase II: Double-blind Placebo |
|---|---|---|---|
| Started | 0 | 28 | 30 |
| Completed | 0 | 25 | 21 |
| Not completed | 0 | 3 | 9 |
We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
| percentage of subjects who relapsed | Phase II: Escitalopram | Phase II: Placebo |
|---|---|---|
| Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS) | 18 | 40 |
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.
| percentage of subjects who responded | Phase I: Open-Label Escitalopram |
|---|---|
| Phase I Response to Escitalopram (as Measured by the BDD-YBOCS) | 67 |
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.
| units on a scale | Phase II: Escitalopram | Phase II: Placebo |
|---|---|---|
| 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 |
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.
| units on a scale | Phase II: Escitalopram | Phase II: Placebo |
|---|---|---|
| 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 |
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.
| Percentage score | Phase II: Escitalopram | Phase II: Placebo |
|---|---|---|
| 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 |
Collected over Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I: Open-Label Escitalopram | — | 0/100 (0%) | 89/100 (89%) |
| Phase II: Escitalopram | — | 0/28 (0%) | 22/28 (78.6%) |
| Phase II: Placebo | — | 0/30 (0%) | 21/30 (70%) |
| Event | Phase I: Open-Label Escitalopram | Phase II: Escitalopram | Phase II: Placebo |
|---|---|---|---|
| FatigueGeneral disorders | 42/100 | 6/28 | 4/30 |
| HeadacheGeneral disorders | 41/100 | 9/28 | 9/30 |
| NauseaGastrointestinal disorders | 36/100 | 3/28 | 4/30 |
| InsomniaPsychiatric disorders | 34/100 | 3/28 | 7/30 |
| Sexual DysfunctionReproductive system and breast disorders | 31/100 | 2/28 | 1/30 |
| Dry MouthGeneral disorders | 28/100 | 1/28 | 3/30 |
| Change in AppetiteMetabolism and nutrition disorders | 23/100 | 1/28 | 3/30 |
| DizzinessGeneral disorders | 6/100 | 1/28 | 6/30 |
| DiarrheaGastrointestinal disorders | 10/100 | 5/28 | 0/30 |
| Cold SymptomsRespiratory, thoracic and mediastinal disorders | 7/100 | 4/28 | 3/30 |
As the primary endpoint is based on participants randomized to Phase II (i.e. those who completed Phase I, met criteria for response, and were willing to continue on in the study), baseline characteristics are provided for the 58 Phase II participants.
| Age, Continuous(years) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| Mean | 37.3 ± 12.4 | 31.8 ± 13.5 | 33.5 ± 12.4 |
| Age, Categorical(Participants) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 27 | 28 | 55 |
| >=65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 8 | 10 | 18 |
| Race (NIH/OMB)(Participants) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 24 | 27 | 51 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 24 | 24 | 48 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Phase II: Escitalopram | Phase II: Placebo | Total |
|---|---|---|---|
| United States | 28 | 30 | 58 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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