EUCTR2012-000418-13-GB进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female between 20 and 65 years of age, inclusive, at the time of randomization.
- •2. Has a current DSM-IV-TR diagnosis of schizophrenia confirmed by the M.I.N.I.
- •3. Is receiving one or two antipsychotic medications, restricted to any of the following allowable agents: amisulpride, aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone, haloperidol, fluphenazine, perphenazine, flupenthixol, melperone, penfluridol, thiothixene, trifluoperazine, and zotepine. Antipsychotics that are unlisted by the protocol (either as allowed or excluded as in Section 5.2.3 of the protocol) may be allowed if approval is obtained from the AbbVie medical monitor prior to randomization.
- •4. Is clinically stable in the residual phase of the illness, as defined by the following criteria:
- •Level of Care: The subject has had no psychiatric inpatient hospitalization, no overnight crisis stabilization, no emergency room visit for psychiatric symptoms, and no other overt signs of destabilization in the 4 months prior to Screening Visit 1.
- •Stability of Medication Regimen: The subject has had no symptom-related changes in antipsychotic, antidepressant, or mood-stabilizing medications within 8 weeks prior to Day –1 and no changes in dose(s) of those medications for any reason within 4 weeks prior to Day –1.
- •Severity of Symptoms: Core positive symptoms are no worse than moderate in severity, extrapyramidal symptoms (EPS) are no worse than mild in severity, and depressive symptoms are not consistent with a major depressive episode from the start of Screening through the end of the Prospective Stabilization Period, as defined by the following:
- •o Positive and Negative Syndrome Scale (PANSS) item scores of = 5 each for delusions (P1), conceptual disorganization (P2), hallucinatory behavior (P3), and excitement (P4);
- •o In the Investigator's judgment, no clinically significant EPS at Screening Visit 1, a Severity of Abnormal Movements item score of = 2 on the Abnormal Involuntary Movement Scale (AIMS) at Day –1, and a Global Clinical Rating of Akathisia score of = 2 on the Barnes Akathisia Rating Scale (BAS) at Day –1;
- •o Calgary Depression Scale for Schizophrenia (CDSS) total score of = 10 at Screening Visit 1.
- •5. Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Screening Visit 1. A subject who is hospitalized for social reasons but is otherwise symptomatically stable is acceptable.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 430
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
- •2. Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines at Screening Visit 1, Screening Visit 2 or Day –1.
- •3. Has either a body mass index (BMI) > 45 kg/m2 or a body weight >145 kg at Screening Visit 1. BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m2).
- •4. Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
- •5. Has a clinically significant abnormal ECG at Screening Visit 1 as determined by the Investigator.
- •6. Has any risk factors for Torsades de Pointes (TdP)
研究者
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