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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Film-coated tablet containing 25 mg of fluvoxamine maleate
Placebo tablet matching to fluvoxamine maleate
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
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
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
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.
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Time frame: Baseline and weeks 2, 4, 6, 8 and 10
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
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
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
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
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
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
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.
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.