Principle standards and problems regarding proof of efficacy in clinical psychopharmacology.

Abstract:

:Proof of efficacy of a psychotropic medicinal product is the key point of clinical psychopharmacology. This especially concerns the licensing of a new compound, but apart from this special case, lots of efficacy questions need to be answered in clinical psychopharmacology, such as, e.g. the question of the efficacy of a combination therapy. The methodology of the scientific proof of efficacy has already had a long tradition and has been developed further in the recent past under different aspects. Especially the double-blind randomised parallel group comparison has been developed as a design of highest methodological standard. However, often designs have their place and justification under certain conditions and in relation to certain questions. Although in the recent past, with the over-emphasis of so-called effectiveness studies, the inherent methodological limitations of these studies have not been addressed properly (Möller in Eur Arch Psychiatry Clin Neurosci 258:257-270, 2008), which in consequence devaluated the scientific merits of the classical double-blind randomised control group study designs in the view of those colleagues, who are not that experienced in study design issues. Therefore, it seems to be timely and necessary to review the principle standards and problems concerning the proof of efficacy in clinical psychopharmacology.

authors

Möller HJ,Broich K

doi

10.1007/s00406-009-0071-8

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

3-16

issue

1

eissn

0940-1334

issn

1433-8491

journal_volume

260

pub_type

杂志文章
  • Binocular rivalry transitions predict inattention symptom severity in adult ADHD.

    abstract::Attention deficit and hyperactivity disorder (ADHD) is a prevalent childhood disorder that is often maintained throughout the development and persists into adulthood. Established etiology models suggest that deficient inhibition underlies the core ADHD symptoms. While experimental evidence for impaired motor inhibitio...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-017-0790-1

    authors: Jusyte A,Zaretskaya N,Höhnle NM,Bartels A,Schönenberg M

    更新日期:2018-06-01 00:00:00

  • Psychopathology in dual diagnosis and non-addicted schizophrenics--are there differences?

    abstract::In a previous publication we reported lifetime and 3-month prevalence estimates for substance use in two large samples of schizophrenic inpatients (Soyka et al. 1993). A subsequent analysis of psychopathological findings assessed by means of the AMDP Manual (Guy and Ban 1982) in schizophrenic in-patients of the Haar M...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s004060170032

    authors: Soyka M,Albus M,Immler B,Kathmann N,Hippius H

    更新日期:2001-10-01 00:00:00

  • Altered intrinsic organisation of brain networks implicated in attentional processes in adult attention-deficit/hyperactivity disorder: a resting-state study of attention, default mode and salience network connectivity.

    abstract::Deficits in task-related attentional engagement in attention-deficit/hyperactivity disorder (ADHD) have been hypothesised to be due to altered interrelationships between attention, default mode and salience networks. We examined the intrinsic connectivity during rest within and between these networks. Six-minute resti...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-015-0630-0

    authors: Sidlauskaite J,Sonuga-Barke E,Roeyers H,Wiersema JR

    更新日期:2016-06-01 00:00:00

  • Relationship of anger and anger attacks with depression: a brief review.

    abstract::Anger is a common and potentially destructive emotion that has considerable social and public health importance. The occurrence of anger, irritability and hostility in depression have been known for many years, but the prevalence, significance for treatment and prognosis and the mechanisms involved remain poorly under...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,评审

    doi:10.1007/s00406-004-0539-5

    authors: Painuly N,Sharan P,Mattoo SK

    更新日期:2005-08-01 00:00:00

  • Dopamine D1 receptor number--a sensitive PET marker for early brain degeneration in Huntington's disease.

    abstract::D1-dopamine receptor binding in the brain was determined by positron emission tomography (PET) in five patients with Huntington's disease, in one asymptomatic gene carrier and in five control subjects. [11C] SCH 23390 was used as the radioligand. Brain morphology was recorded by MRI. The patients who all had a mild to...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/BF02191583

    authors: Sedvall G,Karlsson P,Lundin A,Anvret M,Suhara T,Halldin C,Farde L

    更新日期:1994-01-01 00:00:00

  • Acute placebo-controlled sleep laboratory studies and clinical follow-up with pramipexole in restless legs syndrome.

    abstract::In a single-blind, placebo-controlled crossover trial, the acute efficacy of the dopamine agonist pramipexole was investigated in 11 restless legs syndrome (RLS) patients by sleep laboratory methods, with a clinical follow-up for 4 weeks. In 3 nights (pre-treatment, placebo and drug night), objective sleep quality was...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 临床试验,杂志文章

    doi:10.1007/s00406-002-0380-7

    authors: Saletu M,Anderer P,Saletu-Zyhlarz G,Hauer C,Saletu B

    更新日期:2002-08-01 00:00:00

  • Increased plasma levels of soluble TNF receptor I in patients with bipolar disorder.

    abstract::Bipolar disorder (BD) has been associated with a proinflammatory state in which TNF-α seems to play a relevant role. The aim of the present study was to evaluate the plasma levels of TNF-α and its soluble receptors (sTNFR1 and sTNFR2) in BD patients in mania and euthymia in comparison with control subjects. We evaluat...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-010-0116-z

    authors: Barbosa IG,Huguet RB,Mendonça VA,Sousa LP,Neves FS,Bauer ME,Teixeira AL

    更新日期:2011-03-01 00:00:00

  • Psychiatric comorbidity and functional impairment in a clinically referred sample of adults with attention-deficit/hyperactivity disorder (ADHD).

    abstract:OBJECTIVE:This exploratory study aims to compare lifetime psychiatric axis-I-comorbidity and psychosocial functioning in a clinically referred sample of adult patients with attention-deficit/hyperactivity disorder (ADHD) with a population-based healthy control group and to examine whether patients with ADHD and lifetim...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-007-0712-8

    authors: Sobanski E,Brüggemann D,Alm B,Kern S,Deschner M,Schubert T,Philipsen A,Rietschel M

    更新日期:2007-10-01 00:00:00

  • Prospective long-term follow-up of depressed patients with and without suicide attempts.

    abstract::This 4-6-year prospective follow-up study compared reactive depressives with (n = 48) and without suicide attempts before index admission (n = 24). Both groups showed a favourable course and outcome concerning psychiatric diagnoses (DSM-III), psychopathology, social integration, and social functioning as well as displ...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/BF02190337

    authors: Bronisch T,Hecht H

    更新日期:1992-01-01 00:00:00

  • Sleep homeostasis in alcohol-dependent, depressed and healthy control men.

    abstract::Visually scored and power spectral analyses (PSA) of polysomnography (PSG) recordings reveal abnormalities in alcohol dependence (AD) and major depressive disorder (MDD), including deficiencies in slow wave activity (SWA) during non-rapid eye movement (NREM) sleep. SWA parameters reflect the integrity of the homeostat...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-011-0195-5

    authors: Brower KJ,Hoffmann R,Conroy DA,Arnedt JT,Armitage R

    更新日期:2011-12-01 00:00:00

  • A 10-year matched-pairs study comparing azathioprine and no immunosuppression in multiple sclerosis.

    abstract::In a retrospective matched-pairs study the efficacy of azathioprine treatment was compared with no treatment over a period of at least 10 years. Of 277 patients with clinically definite multiple sclerosis seen during the years 1973 and 1974, 42 pairs were selected by similarity in disability score, sex, age and diseas...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/BF02190090

    authors: Kappos L,Heun R,Mertens HG

    更新日期:1990-01-01 00:00:00

  • Gonadal hormones in schizophrenia and mood disorders.

    abstract::There are gender-related differences in the prevalence, course and treatment response characteristics of schizophrenia and mood disorders. Gonadal steroids exert potent effects on mood, cognition and behavior, and there is little doubt that androgens are crucial for differentiating to each gender. Serum level of total...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-003-0424-7

    authors: Ozcan ME,Banoglu R

    更新日期:2003-08-01 00:00:00

  • Twin-based study of the complex interplay between childhood maltreatment, socioeconomic status and adult memory.

    abstract::Childhood maltreatment and low socioeconomic status (SES) are considered stressful environmental events with lasting detrimental effects on adult mental health and associated cognitive performance, such as memory. However, the association between childhood maltreatment and low SES remains unclear, probably due to desi...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-012-0382-z

    authors: Goldberg X,Alemany S,Fatjó-Vilas M,González-Ortega I,González-Pinto A,Cuesta MJ,Fañanás L

    更新日期:2013-08-01 00:00:00

  • Reexamination of the characteristics of the deficit schizophrenia patients.

    abstract::The aim of this study was to reexamine and compare the characteristics of the deficit and nondeficit schizophrenic patients. This cross-sectional study consisted of 62 in- and out-patients, 18-65 years of age, diagnosed with schizophrenia according to DSM-IV. The sociodemographic variables, premorbid adjustment, clini...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-003-0434-5

    authors: Tiryaki A,Yazici MK,Anil AE,Kabakçi E,Karaağaoğlu E,Göğüş A

    更新日期:2003-10-01 00:00:00

  • Characterization of spontaneous Parkinsonism in drug-naive patients with nonaffective psychotic disorders.

    abstract::Spontaneous Parkinsonism (SP) in schizophrenia-related disorders is poorly characterized. The objective of this study was to examine the concordance and clinical validity of alternative definitions of SP in patients with nonaffective psychotic disorders. Two-hundred drug-naive patients with nonaffective psychotic diso...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-011-0219-1

    authors: Peralta V,Basterra V,Campos MS,de Jalón EG,Moreno-Izco L,Cuesta MJ

    更新日期:2012-03-01 00:00:00

  • The intraindividual impact of ADHD on the transition of adulthood to old age.

    abstract::The aim of the study was to explore whether the individual burden of ADHD is the same in the elderly as in younger ages even though the symptomatological impact of ADHD seems to remain stable over the lifespan. To assess ADHD symptoms and ADHD-associated problems in daily life, standardised questionnaires were conduct...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-015-0644-7

    authors: Philipp-Wiegmann F,Retz-Junginger P,Retz W,Rösler M

    更新日期:2016-06-01 00:00:00

  • Quality indicators for mental healthcare in the Danube region: results from a pilot feasibility study.

    abstract::Quality indicators are vital for monitoring the transformation of institution-based mental health services towards the provision of person-centered mental healthcare. While several mental healthcare quality indicators have been identified as relevant and valid, their actual usability and utility for routine monitoring...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-020-01124-z

    authors: Gaebel W,Lehmann I,Chisholm D,Hinkov H,Höschl C,Kapócs G,Kurimay T,Tosevski DL,Milosavljevic M,Nakov V,Winkler P,Zielasek J

    更新日期:2020-04-08 00:00:00

  • Regional cerebral blood flow in obsessive-compulsive patients with and without a chronic tic disorder. A SPECT study.

    abstract::The main goal of the present study was to explore whether regional cerebral blood flow (rCBF) differs between obsessive-compulsive disorder (OCD) patients without chronic motor tic disorder and those OCD patients with a comorbid chronic tic disorder. Twenty-seven patients suffering from OCD (DSM-IV criteria), includin...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s004060050081

    authors: Crespo-Facorro B,Cabranes JA,López-Ibor Alcocer MI,Payá B,Fernández Pérez C,Encinas M,Ayuso Mateos JL,López-Ibor JJ Jr

    更新日期:1999-01-01 00:00:00

  • The ability of teacher reports to identify child sexual abuse victims.

    abstract::This study concerns the validation of an instrument, the SAB2, designed to measure child behaviour and to help identify emotional problems which arise because the child has been a victim of child sexual abuse. Clinically disturbed children, mainstream school children and sexually abused youngsters were assessed. Relia...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/BF02916247

    authors: Hildreth AJ,Place M

    更新日期:1997-01-01 00:00:00

  • Cognitive predictors of skill acquisition on social problem solving in patients with schizophrenia.

    abstract::The aim of the study was to evaluate the relationship between social problem solving ability, clinical features and cognitive functions, and determine the predictors of benefit from social problem solving training in 63 patients with schizophrenia. We administered Brief Psychiatric Rating Scale (BPRS), Wisconsin Card ...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s00406-006-0651-9

    authors: Uçok A,Cakir S,Duman ZC,Dişcigil A,Kandemir P,Atli H

    更新日期:2006-09-01 00:00:00

  • Surface morphology of the orbitofrontal cortex in individuals at risk of psychosis: a multicenter study.

    abstract::Changes in the surface morphology of the orbitofrontal cortex (OFC), such as a fewer orbital sulci and altered sulcogyral pattern of the 'H-shaped' orbital sulcus, have been reported in schizophrenia, possibly reflecting abnormal neurodevelopment during gestation. However, whether high-risk subjects for developing psy...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s00406-018-0890-6

    authors: Nakamura M,Takahashi T,Takayanagi Y,Sasabayashi D,Katagiri N,Sakuma A,Obara C,Koike S,Yamasue H,Furuichi A,Kido M,Nishikawa Y,Noguchi K,Matsumoto K,Mizuno M,Kasai K,Suzuki M

    更新日期:2019-06-01 00:00:00

  • The relation between sleep and pain among a non-clinical sample of young adults.

    abstract::Poor sleep is linked to poorer daily functioning and increased risk of psychiatric symptoms. With respect to pain, the relation is bi-directional; poor sleep exacerbates pain, while greater pain adversely affects sleep. Moreover, perception of pain is subject to cognitive-emotional processes. Surprisingly, no data are...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-010-0113-2

    authors: Brand S,Gerber M,Pühse U,Holsboer-Trachsler E

    更新日期:2010-10-01 00:00:00

  • Asymmetry of the ventricle and age at the onset of schizophrenia.

    abstract::The relationship between lateral ventricular size or its asymmetry and age at the onset of schizophrenia was investigated in 20 schizophrenic patients diagnosed according to DSM-III-R criteria. The ventricle-brain ratio (VBR) was determined using three transaxial slices of magnetic resonance image (MRI) and asymmetry ...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/BF02193086

    authors: Aso M,Kurachi M,Suzuki M,Yuasa S,Matsui M,Saitoh O

    更新日期:1995-01-01 00:00:00

  • Avoidance behaviour: a predictor of the efficacy of pharmacotherapy in panic disorder?

    abstract::The impact of the avoidance behaviour on the psychopharmacological treatment of panic disorder was explored in the Cross National Collaborative Panic Study (n = 1134 patients); in this double blind randomized trial alprazolam, imipramine and placebo were compared during an 8-week treatment period. Patients with extens...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1007/BF02219714

    authors: Maier W,Roth SM,Argyle N,Buller R,Lavori P,Brandon S,Benkert O

    更新日期:1991-01-01 00:00:00

  • The work of Emil Kraepelin and his research group in München.

    abstract::Emil Kraepelin is well known due to his development of the psychiatric classification. The ICD-10 and DSM-IV classification is based on the dichotomy of endogenous psychoses into affective psychoses and schizophrenia as early as 1899. Moreover, beside his classification system he put enormous impact on the development...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 传,历史文章,杂志文章

    doi:10.1007/s00406-008-2001-6

    authors: Hippius H,Müller N

    更新日期:2008-06-01 00:00:00

  • Glutamate in the mammalian CNS.

    abstract::The excitatory amino acid glutamate plays an important role in the mammalian CNS. Studies conducted from 1940 to 1950 suggested that oral administration of glutamate could have a beneficial effect on normal and retardate intelligence. The neurotoxic nature of glutamate resulting in excitotoxic lesions (neuronal death)...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,评审

    doi:10.1007/BF02189982

    authors: Sahai S

    更新日期:1990-01-01 00:00:00

  • What are residual symptoms in schizophrenia spectrum disorder? Clinical description and 1-year persistence within a naturalistic trial.

    abstract::The aim of this study was to evaluate residual symptoms in patients achieving remission according to the consensus criteria and to analyze their potential influence on the patient's outcome one year after discharge. In total, 399 patients suffering from a schizophrenia spectrum disorder were evaluated within a natural...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s00406-014-0528-2

    authors: Schennach R,Riedel M,Obermeier M,Spellmann I,Musil R,Jäger M,Schmauss M,Laux G,Pfeiffer H,Naber D,Schmidt LG,Gaebel W,Klosterkötter J,Heuser I,Maier W,Lemke MR,Rüther E,Klingberg S,Gastpar M,Möller HJ

    更新日期:2015-03-01 00:00:00

  • Cannabis use influence on peripheral brain-derived neurotrophic factor levels in antipsychotic-naïve first-episode psychosis.

    abstract::The objective of this study is to determine whether cannabis influences BDNF levels in patients with psychosis (FEP) and healthy volunteers (HV) to help understand the role of BDNF in psychosis. We assessed the association between BDNF and cannabis in a cohort of FEP antipsychotic-naïve patients and HV, whilst control...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章

    doi:10.1007/s00406-020-01117-y

    authors: Toll A,Bergé D,Burling K,Scoriels L,Treen D,Monserrat C,Marmol F,Duran X,Jones PB,Pérez-Solà V,Fernandez-Egea E,Mané A

    更新日期:2020-10-01 00:00:00

  • Fluoxetine once every third day in the treatment of major depressive disorder.

    abstract:OBJECTIVE:Fluoxetine and its active metabolite norfluoxetine have long half-lives. We postulate that, owing to the long elimination half-life and the time to reach steady-state level in plasma is nearly four weeks, patients diagnosed with major depressive disorder might be treated with fluoxetine taken once every third...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1007/s00406-003-0445-2

    authors: Tural U,Onder E

    更新日期:2003-12-01 00:00:00

  • Mental health care in Germany: current state and trends.

    abstract::Germany turned towards community-based mental health care in the mid seventies, during a general climate of social and political reform. The continuing deinstitutionalisation process and the implementation of community mental health services was considerably affected by the reunification of East and West Germany in 19...

    journal_title:European archives of psychiatry and clinical neuroscience

    pub_type: 杂志文章,评审

    doi:10.1007/s00406-006-0696-9

    authors: Salize HJ,Rössler W,Becker T

    更新日期:2007-03-01 00:00:00