Obsessive Compulsive DisorderPhase 3NCT01933919
A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder
A Phase 3 study testing Fluvoxamine maleate in people with Obsessive Compulsive Disorder, run by AbbVie.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Fluvoxamine maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2013to 1 Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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).
- Subject has obsessive compulsive disorder symptoms at least for 2 months at informed consent.
- Body weight: ≥ standard weight - 2 standard deviation based on the standard weight for each age in the School Health Statistical Survey 2001.
- 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).
Who cannot join
- 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.
- 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.
- 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]).
Show all 13Show fewer
- 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.
- Subject who diagnose Major Depressive Disorder by The Mini-International Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period.
- 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.
About this study
Official title: A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder
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.
Read the 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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Fluvoxamine maleate, Placebo
- Keywords
- Obsessive Compulsive Disorder, Adolescent Subjects, Pediatric Subjects
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluvoxamine maleateDrug
Also called SME3110, Luvox, Depromel
Film-coated tablet containing 25 mg of fluvoxamine maleate
PlaceboDrug
Placebo tablet matching to fluvoxamine maleate
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet 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 one tablet/day/week up to a maximum of three tablets twice a day. From weeks 7 to 10 participants received the same dose that was given during 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. Receives: Drug: Fluvoxamine maleate; Drug: Placebo |
| Fluvoxamine | Experimental | 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 during 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 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. Receives: Drug: Fluvoxamine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 10
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Worse
- Very much worse
Much improved includes CGI score categories 'very much improved' and 'much improved'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Worse
- Very much worse
Much improved includes CGI score categories 'very much improved' and 'much improved'.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start14 Aug 2013
- Primary completion18 Jun 2015
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meiji Seika Pharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Susumu Matsuki, BS, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933919
- Sponsor's protocol ID
- M13-970
- Status last verified
- Jun 2017
- First submitted
- 29 Aug 2013
- Last updated
- 4 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01933919
- Acronym / sponsor ID
- M13-970
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Adolescent Subjects, Pediatric Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Meiji Seika Pharma Co., Ltd.
- Study start
- 14 Aug 2013 (actual)
- Primary completion
- 18 Jun 2015 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 4 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Fluvoxamine maleate, Drug: PlaceboIn the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet 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 one tablet/day/week up to a maximum of three tablets twice a day. From weeks 7 to 10 participants received the same dose that was given during 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. |
| Fluvoxamine | Experimental | Drug: Fluvoxamine maleateIn 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 during 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 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- 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).
- Subject has obsessive compulsive disorder symptoms at least for 2 months at informed consent.
- Body weight: ≥ standard weight - 2 standard deviation based on the standard weight for each age in the School Health Statistical Survey 2001.
- 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).
Key exclusion criteria (13 listed)
- 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.
- 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.
- Subject is diagnosed with the following psychiatric disorders.
- Subject who diagnose Major Depressive Disorder by The Mini-International Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluvoxamine maleateAlso: SME3110, Luvox, DepromelFilm-coated tablet containing 25 mg of fluvoxamine maleate | Drug | Fluvoxamine, placebo |
| PlaceboPlacebo tablet matching to fluvoxamine maleate | Drug | placebo |
Primary outcome
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
Time frame: 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.
11 secondary outcomes
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age
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
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
Time frame: Baseline and weeks 2, 4, 6, 8 and 10
JCY-BOCS 10-item Total Score at Each Visit During the First Phase
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
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
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
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
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
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susumu Matsuki, BS study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluvoxamine maleate in people with Obsessive Compulsive Disorder, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.