Placebo tablet matching to fluvoxamine maleate

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.

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.

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.

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'.

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.

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.

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.

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'.

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.

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.

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.

Total of all reporting groups

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.

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.

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.

Full analysis set for the first phase; last observation carried forward imputation was used.

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.

Full analysis set for the 1st phase; last observation carried forward imputation was used.

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.

Full analysis set for the 1st phase; participants with available data at each time point.

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.

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.

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'.

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.

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.

Full analysis set for the first phase; last observation carried forward imputation was used.

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.

Full analysis set for the first phase; last observation carried forward imputation was used.

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.

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.

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'.

Full analysis set for the 2nd phase; last observation carried forward imputation was used for the last post-baseline visit assessment.

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.

Participants who received the study drug at least once in the first 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.

Participants who received the study drug at least once in the second phase.

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 who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine 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.

In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine 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.