Trial Outcomes & Findings for Quetiapine XR for Cognitive and Functional Disability in Clinically Stable Patients With Bipolar Disorder (NCT NCT00746421)

Results Overview

The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

6 weeks

Results posted on

2014-04-17

Participant Flow

Recruitment period continued until April 2012 and occurred in medical clinics and through advertisements.

There was a run-in period to ensure mood stability before randomization. Some patients were lost to follow up during this period.

Participant milestones

Participant milestones
Measure	Quetiapine XR Group Quetiapine XR 200-400 mg/day	Placebo Group Placebo one pill per day matching 200, 300, or 400 mg active medications
Overall Study STARTED	12	11
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quetiapine XR for Cognitive and Functional Disability in Clinically Stable Patients With Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine XR Group n=12 Participants Quetiapine XR 200-400 mg/day	Placebo Group n=11 Participants Placebo one pill per day matching 200, 300, or 400 mg active medications	Total n=23 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	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	42.6 years STANDARD_DEVIATION 13.9 • n=7 Participants	40 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.

The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.

Outcome measures

Outcome measures
Measure	Quetiapine XR Group n=5 Participants Quetiapine XR 200-400 mg/day	Placebo Group n=9 Participants Placebo one pill per day matching 200, 300, or 400 mg active medications
The Continuous Performance Test-Identical Pairs Version	2.5 units on a scale Standard Deviation 0.82	2.8 units on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: 6 weeks

Population: The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.

This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).

Outcome measures

Outcome measures
Measure	Quetiapine XR Group n=5 Participants Quetiapine XR 200-400 mg/day	Placebo Group n=9 Participants Placebo one pill per day matching 200, 300, or 400 mg active medications
Brief Assessment of Cognition for Affective Disorders (BAC-A)	49.6 units on a scale (composite t-score) Standard Deviation 12.1	47.8 units on a scale (composite t-score) Standard Deviation 11.5

Adverse Events

Quetiapine XR Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quetiapine XR Group n=12 participants at risk Quetiapine XR 200-400 mg/day	Placebo Group n=11 participants at risk Placebo one pill per day matching 200, 300, or 400 mg active medications
Psychiatric disorders sedation	83.3% 10/12 • Number of events 10	0.00% 0/11

Additional Information

Jeffrey Rakofsky, MD

Emory University

Phone: 404-712-5083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60