Obsessive Compulsive Disorder
Conditions
Keywords
Obsessive Compulsive Disorder, Adolescent Subjects, Pediatric Subjects
Brief summary
The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD). The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
Detailed description
The first phase will be conducted in a randomized, placebo-controlled, double-blind manner to evaluate the efficacy of fluvoxamine on change from baseline to the last observation visit in the JCY-BOCS 10-item total score. Eligible patients will be allocated to the fluvoxamine group or placebo group in a 1:1 ratio using the experience of fluvoxamine treatment and age as stratification factors (dynamic allocation). The first phase consists of a screening period of 1-2 weeks, a forced titration dose period of 2 weeks, a dose adjustment period of 4 weeks, a maintained dose period of 4 weeks, and a tapering dose period of 0-4 weeks. The 2nd phase will be conducted in an open-label manner in participants who completed the first phase to evaluate the long-term safety of fluvoxamine. The 2nd phase consists of 3 periods; a forced titration dose period of 2 weeks, a flexible dose period of 50 weeks, and a tapering dose period of 0-4 weeks. After the last dose of study drug (including tapering dose period) or the early termination visit, participants will be followed for up to 30 days.
Interventions
Film-coated tablet containing 25 mg of fluvoxamine maleate
DRUGPlacebo
Placebo tablet matching to fluvoxamine maleate
Sponsors
Meiji Seika Pharma Co., Ltd.
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has at least 16 points on Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and at least 5 points in Obsession sub-total score and in Compulsion sub-total score respectively at the Screening period and Baseline. 2. Subject showed less than 25% reduction in Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score at Baseline compared to the score at the Screening period (Total score at Baseline ≥ Total score at Screening х 0.75). 3. Subject has obsessive compulsive disorder symptoms at least for 2 months at informed consent. 4. Body weight: ≥ standard weight - 2 standard deviation based on the standard weight for each age in the School Health Statistical Survey 2001. 5. Subjects with parent or legal guardian who have received explanation about the purpose, procedure and meaning of the study sufficiently and is willing to give written informed consent for the subject. (if possible, written informed assent will be obtained from the subject).
Exclusion criteria
1. Subject has only trichotillomania (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 312.39) or nail-biting as his/her compulsive symptoms. 2. Subject has Tourette's disorder (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 307.23). However, the simple motor tic is not excluded. 3. Subject is diagnosed with the following psychiatric disorders. * Schizophrenia (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 295.xx) and other psychotic disorders (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 295.40 \[schizophreniform disorder\], 295.70 \[schizoaffective disorder\], 297.1 \[delusional disorder\], 298.8 \[brief psychotic disorder\], 297.3 \[shared psychotic disorder\], 293.xx \[psychotic disorder due to… {indicate the general medical condition}\], substance induced psychotic disorder, 298.9 \[psychotic disorder not otherwise specified\]). * Depressive disorders Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 296.xx \[major depressive disorder\], 296.2x \[single episode\], 296.3x \[recurrent\], 300.4 \[dysthymic disorder\], 311 \[depressive disorder not otherwise specified\]). * Bipolar disorders (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 296.xx \[bipolar I disorder\], 296.0x \[single manic episode\], 296.40 \[most recent episode hypomanic\], 296.4x \[most recent episode manic\], 296.6x \[most recent episode mixed\], 296.5x \[most recent episode depressed\], 296.7 \[most recent episode unspecified\], 296.89 \[bipolar II disorder\], 301.13 \[cyclothymic disorder\], 296.80 \[bipolar disorder not otherwise specified\]). * Mental retardation (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 317 \[mild mental retardation\], 318.0 \[moderate mental retardation\], 318.1 \[severe mental retardation\], 318.2 \[profound mental retardation\], 319 \[mental retardation, severity unspecified\]). * Eating disorders (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 307.1 \[anorexia nervosa\], 307.51 \[bulimia nervosa\], 307.50 \[eating disorder not otherwise specified\]). * Attention-deficit/hyperactivity disorder (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 314.xx) and attention deficit/hyperactivity disorder not otherwise specified (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 314.9). * Obsessive compulsive personality disorder (Diagnostic and Statistical manual of Mental Disorders Forth Edition Text Revision: 301.4). * Other patients with clinical neurological disorder. 4. Subject who diagnose Major Depressive Disorder by The Mini-International Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period. 5. Subject has been treated with fluvoxamine within 2 months prior to informed consent. Except for the patient whose fluvoxamine dose is not fixed and the administration period of fluvoxamine is within 6 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase | Baseline and week 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender | Baseline and week 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
| Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Baseline and weeks 2, 4, 6, 8 and 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
| JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Baseline and weeks 2, 4, 6, 8 and 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
| Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Weeks 1, 2, 3, 4, 5, 6, 8, and 10 | The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'. |
| Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | Baseline and week 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
| Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age | Baseline and week 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
| Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Baseline of the 2nd phase and weeks 2, 8, 16, 28, 40, and 52 of the 2nd phase | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. Baseline for the 2nd phase was the first visit of the 2nd phase after completion of the tapering period in the first phase and prior to study drug administration in the 2nd phase. |
| Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Baseline of the 2nd phase and weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication in the 2nd phase: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'. |
| Number of Participants With Adverse Events During the First Phase | From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 18 weeks in the first phase. | An adverse event (AE) was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome. |
| Number of Participants With Adverse Events During the Second Phase | From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 60 weeks in the second phase of the study. | An adverse event was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome. |
| Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | Baseline and week 10 | The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. |
Participant flow
Recruitment details
This study was conducted at 34 clinical sites in Japan.
Pre-assignment details
Eligible participants were randomized to placebo or fluvoxamine in a 1:1 ratio. Randomization was stratified by prior fluvoxamine treatment and age (6-11 years or 12-18 years).
Participants by arm
| Arm | Count |
|---|---|
| Fluvoxamine In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.
In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. | 19 |
| Placebo In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week. | 18 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Placebo-controlled Phase | Adverse Event | 0 | 1 |
| Double-blind Placebo-controlled Phase | Lack of Efficacy | 0 | 2 |
| Double-blind Placebo-controlled Phase | Withdrawal by Subject | 0 | 1 |
| Open-label Long-term Phase | Adverse Event | 2 | 0 |
| Open-label Long-term Phase | Lost to Follow-up | 1 | 0 |
| Open-label Long-term Phase | Other | 1 | 2 |
| Open-label Long-term Phase | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Fluvoxamine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 13.7 years STANDARD_DEVIATION 2.83 | 13.3 years STANDARD_DEVIATION 2.72 | 13.5 years STANDARD_DEVIATION 2.74 |
| Age, Customized 12-18 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Customized 6-11 years | 4 Participants | 4 Participants | 8 Participants |
| Japanese version of the Children's Yale-Brown Obsessive Total Score | 25.4 units on a scale STANDARD_DEVIATION 5.92 | 27.1 units on a scale STANDARD_DEVIATION 5.48 | 26.2 units on a scale STANDARD_DEVIATION 5.69 |
| Prior Treatment with Fluvoxamine No | 19 Participants | 17 Participants | 36 Participants |
| Prior Treatment with Fluvoxamine Yes | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 15 |
| other Total, other adverse events | 13 / 19 | 15 / 19 | 15 / 19 | 15 / 15 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 | 1 / 15 |
Outcome results
Primary
Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and week 10
Population: Full analysis set for the 1st phase; last observation carried forward imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluvoxamine | Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase | -10.5 units on a scale | Standard Deviation 5.25 |
| Placebo | Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase | -6.6 units on a scale | Standard Deviation 7.52 |
p-value: 0.04495% CI: [-8.5, -0.1]ANCOVA
Secondary
JCY-BOCS 10-item Total Score at Each Visit During the First Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and weeks 2, 4, 6, 8 and 10
Population: Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 4 | 21.5 units on a scale | Standard Deviation 7.91 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 8 | 17.9 units on a scale | Standard Deviation 6.27 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 2 | 22.7 units on a scale | Standard Deviation 6.72 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 10 | 15.4 units on a scale | Standard Deviation 6.48 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 6 | 17.4 units on a scale | Standard Deviation 7.48 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Last post-baseline visit | 16.1 units on a scale | Standard Deviation 6.84 |
| Fluvoxamine | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Baseline | 26.6 units on a scale | Standard Deviation 5.51 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Last post-baseline visit | 20.7 units on a scale | Standard Deviation 9.21 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Baseline | 27.3 units on a scale | Standard Deviation 5.26 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 2 | 25.1 units on a scale | Standard Deviation 5.83 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 4 | 24.2 units on a scale | Standard Deviation 6.89 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 6 | 22.1 units on a scale | Standard Deviation 8.24 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 8 | 19.6 units on a scale | Standard Deviation 10.46 |
| Placebo | JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 10 | 20.7 units on a scale | Standard Deviation 9.8 |
Secondary
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and weeks 2, 4, 6, 8 and 10
Population: Full analysis set for the 1st phase; participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 4 | -5.1 units on a scale | Standard Deviation 4.95 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 8 | -8.6 units on a scale | Standard Deviation 5.01 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 6 | -8.8 units on a scale | Standard Deviation 6.31 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 10 | -10.8 units on a scale | Standard Deviation 5.29 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 2 | -3.9 units on a scale | Standard Deviation 3.49 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 10 | -7.2 units on a scale | Standard Deviation 7.77 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 2 | -1.6 units on a scale | Standard Deviation 2.29 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 4 | -3.2 units on a scale | Standard Deviation 4.48 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 6 | -5.6 units on a scale | Standard Deviation 5.44 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase | Week 8 | -7.9 units on a scale | Standard Deviation 8.39 |
Secondary
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. Baseline for the 2nd phase was the first visit of the 2nd phase after completion of the tapering period in the first phase and prior to study drug administration in the 2nd phase.
Time frame: Baseline of the 2nd phase and weeks 2, 8, 16, 28, 40, and 52 of the 2nd phase
Population: The full analysis set (FAS) for the 2nd phase (FAS2) included participants who received at least one dose of study drug, and had a baseline and at last one post-baseline measurement for efficacy after week 1 in the 2nd phase. Last observation carried forward imputation was used for the last post-baseline visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Baseline of 2nd phase | 14.8 units on a scale | Standard Deviation 6.62 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 2 | -0.2 units on a scale | Standard Deviation 3.93 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 8 | -1.2 units on a scale | Standard Deviation 2.87 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 16 | -1.3 units on a scale | Standard Deviation 2.95 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 28 | -0.7 units on a scale | Standard Deviation 3.87 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 40 | -1.9 units on a scale | Standard Deviation 3.97 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 52 | -3.1 units on a scale | Standard Deviation 4.48 |
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at last post-baseline visit | -1.7 units on a scale | Standard Deviation 5.48 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at last post-baseline visit | -8.1 units on a scale | Standard Deviation 8.61 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Baseline of 2nd phase | 20.4 units on a scale | Standard Deviation 9.81 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 28 | -6.2 units on a scale | Standard Deviation 6.13 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 2 | -1.1 units on a scale | Standard Deviation 6.55 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 52 | -6.6 units on a scale | Standard Deviation 9.15 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 8 | -4.3 units on a scale | Standard Deviation 7.54 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 40 | -5.6 units on a scale | Standard Deviation 11.02 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase | Change from baseline at week 16 | -7.1 units on a scale | Standard Deviation 8.53 |
Secondary
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and week 10
Population: Full analysis set for the first phase; last observation carried forward imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age | -12.5 units on a scale | Standard Deviation 3 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age | -10.3 units on a scale | Standard Deviation 11.95 |
| Fluvoxamine - Ages 12-18 | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age | -10.0 units on a scale | Standard Deviation 5.67 |
| Placebo - Ages 12-18 | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age | -5.6 units on a scale | Standard Deviation 5.97 |
Secondary
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and week 10
Population: Full analysis set for the 1st phase; last observation carried forward imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluvoxamine | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender | -11.9 units on a scale | Standard Deviation 4.68 |
| Placebo | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender | -7.0 units on a scale | Standard Deviation 8.38 |
| Fluvoxamine - Ages 12-18 | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender | -9.3 units on a scale | Standard Deviation 5.68 |
| Placebo - Ages 12-18 | Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender | -6.0 units on a scale | Standard Deviation 6.51 |
Secondary
Number of Participants With Adverse Events During the First Phase
An adverse event (AE) was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome.
Time frame: From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 18 weeks in the first phase.
Population: Participants who received the study drug at least once in the first phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | Severe adverse event | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | AE leading to discontinuation of study drug | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | Treatment-related adverse event | 6 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | AE leading to death | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | Serious adverse events | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the First Phase | Any adverse event | 13 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | Serious adverse events | 0 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | Treatment-related adverse event | 5 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | Severe adverse event | 0 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | Any adverse event | 15 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | AE leading to discontinuation of study drug | 1 participants |
| Placebo | Number of Participants With Adverse Events During the First Phase | AE leading to death | 0 participants |
Secondary
Number of Participants With Adverse Events During the Second Phase
An adverse event was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome.
Time frame: From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 60 weeks in the second phase of the study.
Population: Participants who received the study drug at least once in the second phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | Treatment-related adverse event | 7 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | Serious adverse event | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | AE leading to discontinuation of study drug | 2 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | Any adverse event | 15 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | AE leading to death | 0 participants |
| Fluvoxamine | Number of Participants With Adverse Events During the Second Phase | Severe adverse event | 0 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | AE leading to death | 0 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | Any adverse event | 15 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | Treatment-related adverse event | 7 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | Severe adverse event | 0 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | AE leading to discontinuation of study drug | 0 participants |
| Placebo | Number of Participants With Adverse Events During the Second Phase | Serious adverse event | 1 participants |
Secondary
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase
The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'.
Time frame: Weeks 1, 2, 3, 4, 5, 6, 8, and 10
Population: Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 2 | 5.3 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 6 | 38.9 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 4 | 10.5 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 8 | 42.1 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 3 | 5.3 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 10 | 50.0 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 5 | 26.3 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Last post-baseline visit | 52.6 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Last post-baseline visit | 38.9 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 3 | 11.1 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 4 | 5.9 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 5 | 5.9 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 6 | 29.4 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 8 | 43.8 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase | Week 10 | 43.8 percentage of participants |
Secondary
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase
The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication in the 2nd phase: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'.
Time frame: Baseline of the 2nd phase and weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Full analysis set for the 2nd phase; last observation carried forward imputation was used for the last post-baseline visit assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 6 | 22.2 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 24 | 42.9 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 4 | 16.7 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 28 | 64.3 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 8 | 33.3 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 32 | 57.1 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 3 | 12.5 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 36 | 50.0 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 12 | 29.4 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 40 | 61.5 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 5 | 23.5 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 44 | 50.0 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 16 | 35.7 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 48 | 50.0 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 2 | 5.6 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 52 | 57.1 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 20 | 50.0 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Last post-baseline visit | 42.1 percentage of participants |
| Fluvoxamine | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 1 | 22.2 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Last post-baseline visit | 46.7 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 1 | 7.1 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 2 | 20.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 3 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 4 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 5 | 54.5 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 6 | 46.7 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 8 | 60.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 12 | 53.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 16 | 64.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 20 | 64.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 24 | 53.8 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 28 | 58.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 32 | 40.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 36 | 27.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 40 | 25.0 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 44 | 45.5 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 48 | 27.3 percentage of participants |
| Placebo | Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase | Week 52 | 36.4 percentage of participants |
Secondary
Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and week 10
Population: Full analysis set for the first phase; last observation carried forward imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluvoxamine | Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | 73.7 percentage of participants |
| Placebo | Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | 44.4 percentage of participants |
Secondary
Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase
The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Time frame: Baseline and week 10
Population: Full analysis set for the first phase; last observation carried forward imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluvoxamine | Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | 68.4 percentage of participants |
| Placebo | Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase | 33.3 percentage of participants |