Guanfacine Enhancement of Working Memory: Prospects for Augmenting Cognitive Remediation in the Schizophrenia Spectrum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- MATRICS Consensus Cognitive Battery Score
研究概览
简要总结
This is a study to assess the efficacy augmenting cognitive remediation therapy (CRT) with a pharmacological agent for individuals with schizotypal personality disorder (SPD). Impaired cognition, along with functional and social skill deficits, is a core feature of schizophrenia and schizophrenia spectrum disorders. A better understanding of the cognitive and functional impairments in schizophrenia-related conditions, as well as the identification of interventions that can reduce these impairments, are vital to improving outcomes for individual with these disorders.
详细描述
This study proposes to 1) evaluate the effects of 7.5 weeks of twice weekly cognitive remediation sessions, combined with concurrent administration of 8 weeks of guanfacine/placebo, on performance on cognitive, functional, and social skills performance measures in a sample of SPD patients with proven deficits in these areas. 2) Compare the effect of cognitive remediation therapy + 8 weeks guanfacine with cognitive remediation therapy + placebo on cognition in this schizophrenia spectrum disorder population. 3) Further characterize cognitive impairment in SPD using specific tests of working memory to evaluate the relationship between working memory and functional and social skill outcomes in this population.
The study hypothesizes that:
- While both groups (those receiving CRT + guanfacine or CRT +placebo) will demonstrate improvements in overall cognitive functioning, SPD participants receiving CRT + guanfacine will evidence greater increases in post-treatment performance on our primary outcome measures-MATRICS battery total score, AX-CPT, N-Back, PASAT and DOT Test- particularly in areas related to working memory.
- Participants receiving CRT + guanfacine will also demonstrate greater improvements in functional and social functioning exploratory measures, as evidenced by performance on our secondary assessments, the UPSA, SSPA, MASC, and Reading of the Mind in the Eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and having capacity to provide informed consent
- •Currently meeting DSM-IV-TR criteria for Schizotypal Personality Disorder
- •Males and females between the ages of 18-65
- •Medically healthy: no major or partially treated medical condition that, based on the judgment of the clinician, would either put the patient at increased risk and/or affect our findings.
- •Neurologically healthy: no brain injury or head trauma associated with loss of consciousness, seizures, or other conditions that may have caused functional impairment.
- •At least two weeks free of medication while participating in this study
- •Score at least one standard deviation below normative means on at least one test in the cognitive battery.
- •At least 2 weeks free of psychotropic medication while participating in this study. Medication such as NSAIDS (e.g. Advil), Tylenol, Levothyroxine (if on stable dose 1 month, no symptoms of hypothyroidism and normal thyroid labs), non-centrally acting antihistamines, H2 blockers (e.g. Zantac), PPIs (e.g. Prilosec, Prevacid), and others that do not impact cognitive functioning will be allowed; the study physician will evaluate any medication at the time of the medical clearance on a case by case basis.
排除标准
- •Meet criteria for bipolar I disorder, schizophrenia, schizoaffective disorder, or any other psychotic disorder Clinically significant cardiovascular or neurological conditions, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medial illness
- •Current substance abuse or have met criteria for substance dependence within the last 6 months (excluding nicotine)
- •Currently meeting DSM-IV-TR criteria for Major Depressive Disorder, not better accounted for and secondary to a personality disorder
- •Currently taking psychotropic medications
- •Currently taking any medications (systemic or otherwise) that the study physician determines could interfere with the study medication and put the participant at risk and/or interfere with the data
- •Currently pregnant or lactating
- •Non-English speaking
研究组 & 干预措施
Cognitive Remediation Therapy and placebo
7.5 weeks of twice weekly cognitive remediation sessions
干预措施: Cognitive Remediation Therapy (Behavioral)
Cognitive Remediation Therapy and placebo
7.5 weeks of twice weekly cognitive remediation sessions
干预措施: Placebo (Drug)
Guanfacine and CRT
7.5 weeks of twice weekly cognitive remediation sessions with 8 weeks of guanfacine
干预措施: Cognitive Remediation Therapy (Behavioral)
Guanfacine and CRT
7.5 weeks of twice weekly cognitive remediation sessions with 8 weeks of guanfacine
干预措施: Guanfacine (Drug)
结局指标
主要结局
MATRICS Consensus Cognitive Battery Score
时间窗: Baseline and 7.5 weeks after randomization
Change in score at 7.5 weeks as compared to baseline. MATRICS Consensus Cognitive Battery: Subjects will complete the following MATRICS cognitive assessments. The dependent variable (DV) is the total MATRICS battery score. Trail Making Test (TMT): Part A Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC) Hopkins Verbal Learning Test-Revised (HVLT-R) Weschler Memory Scale-III: Spatial Span Letter Number Span (LNS) Neuropsychological Assessment Battery (NAB): Mazes Brief Visuospatial Memory Test-Revised (BVMT-R) Category Fluency: Animal Naming
次要结局
- Modified version of AX-Continuous Performance Test (AX-CPT) Score(Baseline and 7.5 weeks after randomization)
- UCSD Performance Based Skills Assessment (UPSA) Score(Baseline and 7.5 weeks after randomization)
- Social Skills Performance Assessment (SSPA) Score(Baseline and 7.5 weeks after randomization)
- Reading of the Mind in the Eyes Score(Baseline and 7.5 weeks after randomization)
研究者
Margaret McNamara McClure
Assistant Professor
Icahn School of Medicine at Mount Sinai