Trial Outcomes & Findings for Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder (NCT NCT00632229)

Last Updated: 2014-02-06

Results Overview

This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 \[Scale range: 0 (Minimum) - 40 (Maximum)\] with higher scores corresponding to more severe obsessive-compulsive symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

End of study (8 weeks)

Results posted on

2014-02-06

Participant Flow

Thirty-four adults with a principal diagnosis of OCD were recruited between May 2008 and March 2012.

Participant milestones

Participant milestones
Measure	Paliperidone Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
Overall Study STARTED	17	17
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
Overall Study Adverse Event	6	0
Overall Study Lost to Follow-up	0	3
Overall Study Lack of Efficacy	0	2
Overall Study Undisclosed reasons within the first wee	0	1

Baseline Characteristics

Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone n=17 Participants Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo n=17 Participants Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	42.59 years STANDARD_DEVIATION 9.99 • n=5 Participants	45.7 years STANDARD_DEVIATION 12.27 • n=7 Participants	43.7 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: End of study (8 weeks)

Outcome measures

Outcome measures
Measure	Paliperidone n=17 Participants Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo n=17 Participants Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
Yale Brown Obsessive Compulsive Scale	19.14 Scores on a scale Standard Deviation 11.13	21.24 Scores on a scale Standard Deviation 8.16

SECONDARY outcome

Timeframe: post-treatment

Population: Includes those subjects who were randomized to their respective condition.

This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.

Outcome measures

Outcome measures
Measure	Paliperidone n=17 Participants Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo n=17 Participants Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms	4.09 Scores on a scale Standard Deviation 1.66	4.21 Scores on a scale Standard Deviation 1.29

Adverse Events

Paliperidone

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Paliperidone n=17 participants at risk Recieves study medication Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.	Placebo n=17 participants at risk Placebo comparator Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
Nervous system disorders Headache	23.5% 4/17 • 8 weeks	35.3% 6/17 • 8 weeks
Nervous system disorders Dizziness	17.6% 3/17 • 8 weeks	23.5% 4/17 • 8 weeks
Nervous system disorders Lightheadness	17.6% 3/17 • 8 weeks	17.6% 3/17 • 8 weeks
Eye disorders blurred vision	17.6% 3/17 • 8 weeks	5.9% 1/17 • 8 weeks
Nervous system disorders Muscle Stiffness	23.5% 4/17 • 8 weeks	0.00% 0/17 • 8 weeks
General disorders Somnolence	41.2% 7/17 • 8 weeks	47.1% 8/17 • 8 weeks
General disorders Insomnia	29.4% 5/17 • 8 weeks	29.4% 5/17 • 8 weeks
General disorders Agitation	23.5% 4/17 • 8 weeks	11.8% 2/17 • 8 weeks
Nervous system disorders Shakiness	5.9% 1/17 • 8 weeks	5.9% 1/17 • 8 weeks
Psychiatric disorders Anxiety	5.9% 1/17 • 8 weeks	5.9% 1/17 • 8 weeks
Gastrointestinal disorders dry mouth	23.5% 4/17 • 8 weeks	17.6% 3/17 • 8 weeks
Gastrointestinal disorders Nausea	0.00% 0/17 • 8 weeks	17.6% 3/17 • 8 weeks
Gastrointestinal disorders Constipation	29.4% 5/17 • 8 weeks	5.9% 1/17 • 8 weeks
Renal and urinary disorders Increased need to urinate	23.5% 4/17 • 8 weeks	5.9% 1/17 • 8 weeks
Ear and labyrinth disorders Ear Ringing	11.8% 2/17 • 8 weeks	11.8% 2/17 • 8 weeks
Gastrointestinal disorders Diarrhea	5.9% 1/17 • 8 weeks	11.8% 2/17 • 8 weeks
Reproductive system and breast disorders Galactorrhea	11.8% 2/17 • 8 weeks	0.00% 0/17 • 8 weeks
Gastrointestinal disorders Increased Appetite	29.4% 5/17 • 8 weeks	17.6% 3/17 • 8 weeks
Gastrointestinal disorders Decreased Appetite	5.9% 1/17 • 8 weeks	5.9% 1/17 • 8 weeks

Additional Information

Dr. Eric Storch

University of South Florida

Phone: 727-767-8230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place