NL-OMON54876已完成不适用
Treatment Response in Non-Affective Psychosis. - TRIP
Stichting Rivierduinen0 个研究点目标入组 63 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- First or later episode of psychosis, provided that the patient has not used
- •antipsychotics for at least one year and that lifetime use of antipsychotics
- •does not exceed 6 months.
- •- A rating of at least 4, corresponding to moderately ill, on the positive
- •symptoms item of the severity of illness part of the CGI-SCH at T0 (in case of
- •the common timeline, see study protocol C1 section 3.1) or T1 (in case of the
- •ideal timeline, see study protocol C1 section 3.1).
- •- Age: 18-35 years.
- •- Within the first 5 years after onset of the first psychotic episode.
- •Healthy controls:
- •- Age: 18-35 years.
排除标准
- •General exclusion criteria patients:
- •- Antipsychotic use longer than 9 weeks at the moment of the PET scan.
- •- Current neurological disorder or history of neurological disorder (e.g.
- •epilepsy) or history of severe head trauma (contusio cerebri).
- •- Incompetent to participate in research.
- •- Patients who resist or oppose antipsychotic mediation.
- •- Primary diagnosis of bipolar disorder with psychotic features or major
- •depressive disorder with psychotic features at the start of non-clozapine
- •antipsychotic medication.
- •- Psychotic disorder due to another medical condition or
- •substance/medication-induced psychotic disorder.
- •General exclusion criteria healthy controls:
- •- Current neurological disorder or history of neurological disorder (e.g.
- •epilepsy) or history of severe head trauma (contusio cerebri).
- •- Current psychiatric disorder or history of any psychiatric disorder (DSM-5).
- •- First-degree relative with schizophrenia spectrum disorder (DSM-5).
- •- Incompetent to participate in research.
- •Exclusion criteria related to alcohol, soft/hard-drugs, and medicinal drugs
- •(patients and healthy controls):
- •- Lifetime history of DSM-5 diagnosis of any Substance Use Disorder (except
- •cannabis use disorder in sustained remission (12 months), tobacco use disorder
- •and alcohol use disorder).
- •- Participants who used cannabis on a daily basis for a period of at least two
- •weeks in the year before the first contact with the researcher.
- •- Current use of substances other than tobacco, cannabis or alcohol, such as
- •XTC, cocaine, amphetamine, opioids or GHB.
- •- Subjects with a disorder in the use of cannabis in the year before the
- •baseline assessment.
- •- Positive urine drug screen on the day of the MRI/PET scan (cannabis, cocaine,
- •XTC, opioids, amphetamines).
- •- Current or recent (less than 1 month ago) use of sleep medication (controls
- •- Current or recent (less than 3 months ago) use of psychotropic drugs that may
- •influence the dopamine system (e.g. lithium, sodium valproate, and
- •methylphenidate) or anti-epileptic drugs that may influence the GABAergic
- •and/or glutamatergic systems.
- •The use of benzodiazepines, hypnotics and antidepressants in amounts within the
- •therapeutic range is allowed (patients only).
- •Exclusion criteria directly related to MRI and PET/CT scanning (patients and
- •healthy controls):
- •- Participation in a scientific examination where radiation was used, in the
- •- Contra-indications for MRI (e.g. pacemaker, claustrophobia, pregnancy).
研究者
相似试验
尚未招募
不适用
Treatment Response in Non-Affective PsychosisSchizophrenia, Schizofrenie, psychosis, psychoseNL-OMON28864GGZ Leiden, Rivierduinen; Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre.63
已完成
不适用
Psychotherapy in non-affective psychotic outpatientsF20F25Schizoaffective disordersSchizophreniaDRKS00015627Evangelisches Klinikum Bethel (EvKB), Klinik für Psychiatrie und Psychotherapie130
进行中（未招募）
1 期
A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects with Acute Exacerbation of SchizophreniaSchizophreniaEUCTR2015-003373-15-HUAlkermes Inc401
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of ALKS 3831 in adult patients who have an acute exacerbation of SchizophreniaMedDRA version: 19.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2015-003373-15-BGAlkermes Inc390
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of ALKS 3831 in adult patients who have an acute exacerbation of SchizophreniaMedDRA version: 18.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2015-003373-15-SKAlkermes Inc390