NCT01933919

A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder

Completed Phase 3 Results posted Last updated 4 December 2017

What this trial tests

Phase 3 trial testing Fluvoxamine maleate in Obsessive Compulsive Disorder in 38 participants. Completed in 1 July 2016.

Timeline

14 August 2013

Primary endpoint
18 June 2015

1 July 2016

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	14 August 2013
Primary completion	18 June 2015
Estimated completion	1 July 2016

Drugs / interventions tested

• Fluvoxamine maleate — full drug profile →
• Placebo

Conditions studied

• Obsessive Compulsive Disorder — all drugs for Obsessive Compulsive Disorder →

Sponsor

AbbVie — full company profile →

Who can join

Adults 6 to 18, any sex, with Obsessive Compulsive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Group	Value	95% CI
Fluvoxamine	-10.5	± 5.25
Placebo	-6.6	± 7.52

Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age Secondary · 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.

Group	Value	95% CI
Fluvoxamine - Ages 6-11	-12.5	± 3.00
Placebo - Ages 6-11	-10.3	± 11.95
Fluvoxamine - Ages 12-18	-10.0	± 5.67
Placebo - Ages 12-18	-5.6	± 5.97

Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender Secondary · 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.

Group	Value	95% CI
Fluvoxamine - Males	-11.9	± 4.68
Placebo - Males	-7.0	± 8.38
Fluvoxamine - Females	-9.3	± 5.68
Placebo - Females	-6.0	± 6.51

Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Secondary · 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.

Week 2

Group	Value	95% CI
Fluvoxamine	-3.9	± 3.49
Placebo	-1.6	± 2.29

Week 4

Group	Value	95% CI
Fluvoxamine	-5.1	± 4.95
Placebo	-3.2	± 4.48

Week 6

Group	Value	95% CI
Fluvoxamine	-8.8	± 6.31
Placebo	-5.6	± 5.44

Week 8

Group	Value	95% CI
Fluvoxamine	-8.6	± 5.01
Placebo	-7.9	± 8.39

Week 10

Group	Value	95% CI
Fluvoxamine	-10.8	± 5.29
Placebo	-7.2	± 7.77

JCY-BOCS 10-item Total Score at Each Visit During the First Phase Secondary · 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.

Baseline

Group	Value	95% CI
Fluvoxamine	26.6	± 5.51
Placebo	27.3	± 5.26

Week 2

Group	Value	95% CI
Fluvoxamine	22.7	± 6.72
Placebo	25.1	± 5.83

Week 4

Group	Value	95% CI
Fluvoxamine	21.5	± 7.91
Placebo	24.2	± 6.89

Week 6

Group	Value	95% CI
Fluvoxamine	17.4	± 7.48
Placebo	22.1	± 8.24

Week 8

Group	Value	95% CI
Fluvoxamine	17.9	± 6.27
Placebo	19.6	± 10.46

Week 10

Group	Value	95% CI
Fluvoxamine	15.4	± 6.48
Placebo	20.7	± 9.80

Last post-baseline visit

Group	Value	95% CI
Fluvoxamine	16.1	± 6.84
Placebo	20.7	± 9.21

Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Secondary · 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'.

Week 1

Group	Value	95% CI
Fluvoxamine	0.0
Placebo	0.0

Week 2

Group	Value	95% CI
Fluvoxamine	5.3
Placebo	0.0

Week 3

Group	Value	95% CI
Fluvoxamine	5.3
Placebo	11.1

Week 4

Group	Value	95% CI
Fluvoxamine	10.5
Placebo	5.9

Week 5

Group	Value	95% CI
Fluvoxamine	26.3
Placebo	5.9

Week 6

Group	Value	95% CI
Fluvoxamine	38.9
Placebo	29.4

Week 8

Group	Value	95% CI
Fluvoxamine	42.1
Placebo	43.8

Week 10

Group	Value	95% CI
Fluvoxamine	50.0
Placebo	43.8

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 Secondary · 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.

Group	Value	95% CI
Fluvoxamine	73.7
Placebo	44.4

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 Secondary · 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.

Group	Value	95% CI
Fluvoxamine	68.4
Placebo	33.3

Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Secondary · 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.

Baseline of 2nd phase

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	14.8	± 6.62
Placebo/Fluvoxamine	20.4	± 9.81

Change from baseline at week 2

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-0.2	± 3.93
Placebo/Fluvoxamine	-1.1	± 6.55

Change from baseline at week 8

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-1.2	± 2.87
Placebo/Fluvoxamine	-4.3	± 7.54

Change from baseline at week 16

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-1.3	± 2.95
Placebo/Fluvoxamine	-7.1	± 8.53

Change from baseline at week 28

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-0.7	± 3.87
Placebo/Fluvoxamine	-6.2	± 6.13

Change from baseline at week 40

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-1.9	± 3.97
Placebo/Fluvoxamine	-5.6	± 11.02

Change from baseline at week 52

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-3.1	± 4.48
Placebo/Fluvoxamine	-6.6	± 9.15

Change from baseline at last post-baseline visit

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	-1.7	± 5.48
Placebo/Fluvoxamine	-8.1	± 8.61

Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Secondary · 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'.

Week 1

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	22.2
Placebo/Fluvoxamine	7.1

Week 2

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	5.6
Placebo/Fluvoxamine	20.0

Week 3

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	12.5
Placebo/Fluvoxamine	35.7

Week 4

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	16.7
Placebo/Fluvoxamine	33.3

Week 5

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	23.5
Placebo/Fluvoxamine	54.5

Week 6

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	22.2
Placebo/Fluvoxamine	46.7

Week 8

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	33.3
Placebo/Fluvoxamine	60.0

Week 12

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	29.4
Placebo/Fluvoxamine	53.3

Number of Participants With Adverse Events During the First Phase Secondary · 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.

Any adverse event

Group	Value	95% CI
Fluvoxamine	13
Placebo	15

Treatment-related adverse event

Group	Value	95% CI
Fluvoxamine	6
Placebo	5

Severe adverse event

Group	Value	95% CI
Fluvoxamine	0
Placebo	0

Serious adverse events

Group	Value	95% CI
Fluvoxamine	0
Placebo	0

AE leading to discontinuation of study drug

Group	Value	95% CI
Fluvoxamine	0
Placebo	1

AE leading to death

Group	Value	95% CI
Fluvoxamine	0
Placebo	0

Number of Participants With Adverse Events During the Second Phase Secondary · 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 s

Any adverse event

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	15
Placebo/Fluvoxamine	15

Treatment-related adverse event

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	7
Placebo/Fluvoxamine	7

Severe adverse event

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	0
Placebo/Fluvoxamine	0

Serious adverse event

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	0
Placebo/Fluvoxamine	1

AE leading to discontinuation of study drug

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	2
Placebo/Fluvoxamine	0

AE leading to death

Group	Value	95% CI
Fluvoxamine/Fluvoxamine	0
Placebo/Fluvoxamine	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately18 weeks in the first phase of the study and 60 weeks in the second phase.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

First Phase: Fluvoxamine

Serious: 0/19 (0%)

Deaths: 0/19

First Phase: Placebo

Serious: 0/19 (0%)

Deaths: 0/19

Second Phase: Fluvoxamine/Fluvoxamine

Serious: 0/19 (0%)

Deaths: 0/19

Second Phase: Placebo/Fluvoxamine

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	First Phase: Fluvoxamine	First Phase: Placebo	Second Phase: Fluvoxamine/…	Second Phase: Placebo/Fluv…
Hyperventilation	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (76 terms — click to expand)

Reaction	System	First Phase: Fluvoxamine	First Phase: Placebo	Second Phase: Fluvoxamine/…	Second Phase: Placebo/Fluv…
Nasopharyngitis	Infections and infestations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Irritability	General disorders	—	—	—	—
Arthropod sting	Injury, poisoning and procedural complications	—	—	—	—
Excoriation	Injury, poisoning and procedural complications	—	—	—	—
Blood triglycerides increased	Investigations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—
Eye pain	Eye disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Aphthous stomatitis	Gastrointestinal disorders	—	—	—	—
Chest discomfort	General disorders	—	—	—	—
Drug withdrawal syndrome	General disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Acute tonsillitis	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Heat illness	Injury, poisoning and procedural complications	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—
Muscle contusion	Injury, poisoning and procedural complications	—	—	—	—

Most-reported serious reactions: Hyperventilation.

Data from ClinicalTrials.gov NCT01933919 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.