Trial Outcomes & Findings for The Effects of Rimonabant, on Weight and Metabolic Risk Factors (NCT NCT00547118)

18 participants signed consent for the study. 1 participant was withdrawn prior to randomization, 2 participants (one from each group) withdrawn after randomization but prior to drug initiation. n=15 participants included in data analysis for aims 1, 2, 8, 9, 10, and n=14 analyzed for aims 3-7 due withdrawal prior to EOS neruopsych testing.

The Effects of Rimonabant, on Weight and Metabolic Risk Factors

The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.

The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.

The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.

The Iowa Gambling Task (IGT) is a computer-administered cognitive test that assesses risk preferences by simulating real-life decision making using uncertainty, rewards, and penalties. In the task, players are given four decks of cards and an endowment of fake money (e.g., $2000). Players are instructed to select cards one at a time and try to lose the least amount of money and win the most. The outcome measure was the number of rewarded minus punished card choices. Task has a maximum of 100 trials. The net score is the difference between the number of choices from advantageous decks verses disadvantageous decks. Higher scores are better and can range from -50 to +50.

The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.

The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.

The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.

SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.

SANS Global Anhedonia score. Scores can range from 0-5, with higher scores indicating more severe anhedonia.

SANS Global Rating of Affective Flattening. Scores can range from 0-5, with higher scores indicating more severe blunted affect.

SANS Global Rating of Alogia. Scores can range from 0-5, with higher scores indicating more severe alogia.

SANS Avolition score. Scores can range from 0-5, with higher scores indicating more severe avolition.

The global improvement score can range from 1-7, with higher scores indicating worse total improvement clinically.

The CDS total score is the addition of scores from items 1-9. Each item's scores range on a scale of "0=Absent" to "3=Severe". The total score range is from 0-27. Higher total scores indicate a more severe depression rating.