Trial · NCT00547118
The Effects of Rimonabant, on Weight and Metabolic Risk Factors
NCT00547118, Phase 2, Terminated, University of Maryland, Baltimore; results first posted 2015-02-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Effects of Rimonabant, on Weight and Metabolic Risk Factors. Trials, record NCT00547118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00547118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Rimonabant, on Weight and Metabolic Risk Factors
- NCT number
- NCT00547118
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Schizophrenia, Schizoaffective Disorder, Obesity, Hypertension, Smoking
- Interventions
- Rimonabant, Placebo
- First posted
- 2007-10-22
- Last updated
- 2019-11-04
- Results first posted
- 2015-02-27
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Psychiatric Rating Scale (BPRS) Total Score | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | The Iowa Gambling Task (IGT) | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | N-Back Neurocognitive Task: 0-back Condition | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | N-Back Neurocognitive Task: 1-back Condition | Baseline (Week 0) and end of study (Week 16) | 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. |
| Primary | N-Back Neurocognitive Task: 2-back Condition | Baseline (Week 0) and end of study (Week 16) | 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. |
| Secondary | Schedule for Assessment of Negative Symptoms (SANS) Total Score | Baseline (Week 0) and end of study (Week 16) | SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. |
| Secondary | Schedule for Assessment of Negative Symptoms (SANS) - Anhedonia | Baseline (Week 0) and end of study (Week 16) | SANS Global Anhedonia score. Scores can range from 0-5, with higher scores indicating more severe anhedonia. |
| Secondary | Schedule for Assessment of Negative Symptoms (SANS) - Blunted Affect | Baseline (Week 0) and end of study (Week 16) | SANS Global Rating of Affective Flattening. Scores can range from 0-5, with higher scores indicating more severe blunted affect. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brief Psychiatric Rating Scale (BPRS) Total Score | Baseline (Week 0) and end of study (Week 16) | Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion. | units on a scale | MEAN |
| PRIMARY | Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Baseline (Week 0) and end of study (Week 16) | Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion. | units on a scale | MEAN |
| PRIMARY | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline (Week 0) and end of study (Week 16) | 14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1). | units on a scale | MEAN |
| PRIMARY | The Iowa Gambling Task (IGT) | Baseline (Week 0) and end of study (Week 16) | 14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1). | units on a scale | MEAN |
| PRIMARY | N-Back Neurocognitive Task: 0-back Condition | Baseline (Week 0) and end of study (Week 16) | 14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1). | units on a scale | MEAN |
| PRIMARY | N-Back Neurocognitive Task: 1-back Condition | Baseline (Week 0) and end of study (Week 16) | 14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1). | units on a scale | MEAN |
| PRIMARY | N-Back Neurocognitive Task: 2-back Condition | Baseline (Week 0) and end of study (Week 16) | 14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1). | units on a scale | MEAN |
| SECONDARY | Schedule for Assessment of Negative Symptoms (SANS) Total Score | Baseline (Week 0) and end of study (Week 16) | Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion. | units on a scale | MEAN |
| SECONDARY | Schedule for Assessment of Negative Symptoms (SANS) - Anhedonia | Baseline (Week 0) and end of study (Week 16) | Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion. | units on a scale | MEAN |
| SECONDARY | Schedule for Assessment of Negative Symptoms (SANS) - Blunted Affect | Baseline (Week 0) and end of study (Week 16) | Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion. | units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) Total Score | Rimonabant | Week 0 | 33.5 | Standard Deviation 7.5 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Placebo | Week 0 | 34.5 | Standard Deviation 4.6 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Rimonabant | Week 16 | 32.8 | Standard Deviation 3.9 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Placebo | Week 16 | 33.6 | Standard Deviation 6.2 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Rimonabant | Week 0 | 9.4 | Standard Deviation 4.3 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Placebo | Week 0 | 11.4 | Standard Deviation 3.4 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Rimonabant | Week 16 | 7.6 | Standard Deviation 3.0 | units on a scale |
| Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Placebo | Week 16 | 8.6 | Standard Deviation 3.4 | units on a scale |
| The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Rimonabant | Week 0 | 85.0 | Standard Deviation 19.8 | units on a scale |
| The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Placebo | Week 0 | 78.3 | Standard Deviation 10.2 | units on a scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rimonabant | 8 | |
| Overall Study | STARTED | Placebo | 9 | |
| Overall Study | COMPLETED | Rimonabant | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rimonabant | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Rimonabant | 3 | 8 | |
| other | Headache | General disorders | Placebo | 5 | 9 | |
| other | Enuresis | Renal and urinary disorders | Rimonabant | 3 | 8 | |
| other | Enuresis | Renal and urinary disorders | Placebo | 4 | 9 | |
| other | Anorexia | Metabolism and nutrition disorders | Rimonabant | 3 | 8 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo | 3 | 9 | |
| other | Sedation | Respiratory, thoracic and mediastinal disorders | Rimonabant | 2 | 8 | |
| other | Sedation | Respiratory, thoracic and mediastinal disorders | Placebo | 4 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Rimonabant | 3 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 4 | 9 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rimonabant | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rimonabant | 4 | 8 |
| Total, other adverse events | Placebo | 6 | 9 |
| Total, serious adverse events | Rimonabant | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rimonabant vs Placebo: serious adverse events |
Source Trial comparisons
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
| Iowa Gambling Lite | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00547118
GET https://conductscience.org/api/trials/v1/NCT00547118/results?page=2