Cognitive Enhancement in Bipolar Disorder
NCT00597896, Phase 4, Completed, Northwell Health; results first posted 2015-06-12
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Enhancement in Bipolar Disorder | ClinicalTrials.gov |
| NCT number | NCT00597896 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Northwell Health | ClinicalTrials.gov |
| Conditions | Bipolar Disorder | ClinicalTrials.gov |
| Interventions | pramipexole | ClinicalTrials.gov |
| First posted | 2008-01-18 | ClinicalTrials.gov |
| Last updated | 2015-06-12 | ClinicalTrials.gov |
| Results first posted | 2015-06-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Change from Baseline to Week 8 | The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Change from Baseline to Week 8 | The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Change from Baseline to Week 8 | Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Stroop Color-Word Test | Change from Baseline to Week 8 | The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Trail Making Test Part A | Change from Baseline to Week 8 | The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Trail Making Test Part B | Change from Baseline to Week 8 | The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in d2 Test of Attention | Change from Baseline to Week 8 | The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the "d's" with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Hopkins Verbal Learning Test | Change from Baseline to Week 8 | The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency | Change from Baseline to Week 8 | The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. | ClinicalTrials.gov |
| Secondary | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Change from Baseline to Week 8 | The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64. | ClinicalTrials.gov |
| Secondary | Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint | Change from Baseline to Week 8 | The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 ("Insight") which is rated on a 5-point Likert scale. These items yield two subscale scores-one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74. | ClinicalTrials.gov |
Outcomes 11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | number of correct numbers recalled | MEAN | ClinicalTrials.gov |
| SECONDARY | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | number of correct numbers recalled | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Stroop Color-Word Test | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | words | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Trail Making Test Part A | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Trail Making Test Part B | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in d2 Test of Attention | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Hopkins Verbal Learning Test | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | words | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency | Change from Baseline to Week 8 | All randomized participants were assessed per protocol | words | MEAN | ClinicalTrials.gov |
Results by group 66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Active Pramipexole | Baseline | 8.43 | Standard Deviation 2.93 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Placebo Pramipexole | Baseline | 8.54 | Standard Deviation 3.02 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Active Pramipexole | Week 8 | 8.48 | Standard Deviation 2.40 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Placebo Pramipexole | Week 8 | 8.13 | Standard Deviation 2.52 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Active Pramipexole | Change from Baseline to Week 8 | .05 | Standard Deviation 1.72 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) | Placebo Pramipexole | Change from Baseline to Week 8 | -.41 | Standard Deviation 2.08 | number of correct numbers recalled | ClinicalTrials.gov |
| Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Active Pramipexole | -.9 | Standard Deviation 5.5 | units on a scale | ClinicalTrials.gov | |
| Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Placebo Pramipexole | -1.5 | Standard Deviation 3.2 | units on a scale | ClinicalTrials.gov | |
| Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint | Active Pramipexole | .5 | Standard Deviation 4.0 | units on a scale | ClinicalTrials.gov | |
| Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint | Placebo Pramipexole | -.9 | Standard Deviation 3.0 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Active Pramipexole | Baseline | 6.48 | Standard Deviation 2.09 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Placebo Pramipexole | Baseline | 6.46 | Standard Deviation 2.48 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Active Pramipexole | Week 8 | 6.86 | Standard Deviation 1.96 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Placebo Pramipexole | Week 8 | 6.67 | Standard Deviation 3.09 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Active Pramipexole | Change from Baseline to Week 8 | .38 | Standard Deviation 2.33 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) | Placebo Pramipexole | Change from Baseline to Week 8 | .21 | Standard Deviation 1.35 | number of correct numbers recalled | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Active Pramipexole | Baseline | 8.52 | Standard Deviation 2.64 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Placebo Pramipexole | Baseline | 8.08 | Standard Deviation 2.83 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Active Pramipexole | Week 8 | 9.05 | Standard Deviation 3.46 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test | Placebo Pramipexole | Week 8 | 8.75 | Standard Deviation 3.07 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Active Pramipexole | 24 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo Pramipexole | 26 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Active Pramipexole | 21 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo Pramipexole | 24 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Active Pramipexole | 3 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo Pramipexole | 2 | ClinicalTrials.gov |
Adverse events 4
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 | Source |
|---|---|---|---|---|---|---|---|
| serious | Chest Pain | Respiratory, thoracic and mediastinal disorders | Active Pramipexole | 1 | 21 | ClinicalTrials.gov | |
| serious | Chest Pain | Respiratory, thoracic and mediastinal disorders | Placebo Pramipexole | 1 | 24 | ClinicalTrials.gov | |
| serious | Car accident | General disorders | Active Pramipexole | 1 | 21 | ClinicalTrials.gov | |
| serious | Car accident | General disorders | Placebo Pramipexole | 0 | 24 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Active Pramipexole | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo Pramipexole | ClinicalTrials.gov | ||
| Total, other adverse events | Active Pramipexole | 0 | 21 | ClinicalTrials.gov |
| Total, other adverse events | Placebo Pramipexole | 0 | 24 | ClinicalTrials.gov |
| Total, serious adverse events | Active Pramipexole | 2 | 21 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo Pramipexole | 1 | 24 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 22152405 | RESULT | PubMed |
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Pramipexole vs Placebo Pramipexole: serious adverse events | Trial comparisons |
Tests 8
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 |
|---|---|---|
| Cancellation Test | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)