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Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days |
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| 2 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days |
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| 3 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days |
|
| 4 | Experimental | ABT288 vs placebo administered orally once daily for 14 days |
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| 5 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days |
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| 6 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-288 | Drug | See Arm Description for details. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests, | Days -1 to 21 | |
| Pharmacokinetics; optional CSF for arms 7, 8 & 9 | Days -1 to 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Extrapyramidal Symptom Rating Scale | Day -1, Day 14 | |
| Columbia Suicide Severity Rating Scale | Screening, Day 15 | |
| Pharmacodynamics: CANTAB & PANSS |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24215171 | Background | Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C576396 | 2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one |
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|
| 7 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days |
|
| 8 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days |
|
| 9 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days |
|
| Placebo | Drug | See Arm Description for details. |
|
| Screening, Day -1, Day 14 |
| Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified | Day -1, Day 15 |