Improving treatment of depression in the elderly: two innovations in statistical design of clinical trials.

Abstract:

:Depression in the elderly patient may present special challenges for the design of clinical treatment trials due to a complex antidepressant treatment history, individual contraindications to certain medications, medical comorbidity, as well as concurrent medications for other medical conditions. The chronic, relapsing, and remitting nature of depression calls for a dynamic, adaptive treatment strategy, matching treatment changes to patient responses. To market a drug successfully in a cost-conscious environment, it also may be necessary to define the unique contribution that a new drug makes to the treatment of patients, in addition to proving that it is efficacious (by comparison to placebo). These issues, although not unique to the elderly, take on greater importance and weight as patient populations age. This article describes 2 innovations in clinical trials design that may help deal with these issues.

journal_name

J Clin Psychopharmacol

authors

Lavori PW

doi

10.1097/01.jcp.0000168502.16361.ad

subject

Has Abstract

pub_date

2005-08-01 00:00:00

pages

S38-44

issue

4 Suppl 1

eissn

0271-0749

issn

1533-712X

pii

00004714-200508001-00008

journal_volume

25

pub_type

杂志文章,评审
  • Duration of imipramine therapy and relapse in panic disorder with agoraphobia.

    abstract::It has been suggested that maintenance treatment of patients who have remitted panic disorder with agoraphobia beyond the six months of acute phase imipramine treatment may decrease the risk of relapse. This study further explores the relationship between relapse and duration of imipramine treatment in this population...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00004714-200206000-00010

    authors: Mavissakalian MR,Perel JM

    更新日期:2002-06-01 00:00:00

  • Antidepressant exposure as a predictor of clinical outcomes in the Treatment of Resistant Depression in Adolescents (TORDIA) study.

    abstract::This paper examines the relationship between plasma concentration of antidepressant and both clinical response and adverse effects in treatment-resistant depressed adolescents. Adolescents (n = 334) with major depression who had not responded to a selective serotonin reuptake inhibitor (SSRI) were randomized to 1 of 4...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/JCP.0b013e318204b117

    authors: Sakolsky DJ,Perel JM,Emslie GJ,Clarke GN,Wagner KD,Vitiello B,Keller MB,Birmaher B,Asarnow JR,Ryan ND,McCracken JT,Strober MJ,Iyengar S,Porta G,Brent DA

    更新日期:2011-02-01 00:00:00

  • Plasma haloperidol and clinical response: a role for reduced haloperidol in antipsychotic activity?

    abstract::Seventeen hospitalized psychotic patients were treated with a fixed oral dose of haloperidol, 5 mg twice daily for 28 days. Most were chronic schizophrenics with an acute exacerbation of their illness. All patients also received benztropine 3 mg twice daily during the last 11 days of the study, regardless of the prese...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:

    authors: Shostak M,Perel JM,Stiller RL,Wyman W,Curran S

    更新日期:1987-12-01 00:00:00

  • Lack of efficacy of low doses of quetiapine addition in refractory obsessive-compulsive disorder.

    abstract:BACKGROUND:Some studies have shown that low dose of neuroleptic addition to ongoing antiobsessive treatment might be effective in treatment resistant obsessive-compulsive disorder (OCD). The primary purpose of this study was to evaluate the efficacy of low-dose quetiapine in clomipramine and serotonin reuptake inhibito...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/01.jcp.0000088900.24613.f2

    authors: Sevincok L,Topuz A

    更新日期:2003-10-01 00:00:00

  • Efficacy and safety of venlafaxine in the treatment of bipolar II major depressive episode.

    abstract::As many as 45% of patients with major depression also meet diagnostic criteria for bipolar (BP) II disorder. Although the use of a concurrent mood-stabilizing drug has been suggested in treating BP II depression, antidepressant monotherapy has received less attention. The efficacy and safety of venlafaxine were examin...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00004714-199810000-00010

    authors: Amsterdam J

    更新日期:1998-10-01 00:00:00

  • Zolpidem, triazolam, and temazepam: behavioral and subject-rated effects in normal volunteers.

    abstract::Zolpidem is an imidazopyridine hypnotic that is biochemically distinct from classic benzodiazepine agonists in that it may be selective for the BZ1 receptor subtype and shows a different pattern of distribution of binding sites. The present study compared the learning, recall, performance, subject-rated and observer-r...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00004714-199604000-00007

    authors: Rush CR,Griffiths RR

    更新日期:1996-04-01 00:00:00

  • Aripiprazole in schizophrenia with cocaine dependence: a pilot study.

    abstract::The debilitation of schizophrenia (SCHZ) worsens markedly with comorbid cocaine dependence (CD) and alcohol abuse. To date, no medications have conclusively demonstrated effects against both SCHZ and CD (SCHZ + CD) simultaneously. Because of its dopamine-modulating properties, we hypothesized that aripiprazole would a...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/01.jcp.0000169419.38899.5b

    authors: Beresford TP,Clapp L,Martin B,Wiberg JL,Alfers J,Beresford HF

    更新日期:2005-08-01 00:00:00

  • Accuracy of Clinician Assessments of Medication Status in the Emergency Setting: A Comparison of Clinician Assessment of Antipsychotic Usage and Plasma Level Determination.

    abstract:PURPOSE:The present study aimed to assess the level of agreement between clinicians' routine assessments of medication status and plasma levels of commonly prescribed antipsychotic medications in patients presenting to an emergency room with an exacerbation of psychosis. METHODS:We studied 105 patients presenting to a...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/JCP.0000000000000697

    authors: Lopez LV,Shaikh A,Merson J,Greenberg J,Suckow RF,Kane JM

    更新日期:2017-06-01 00:00:00

  • No difference in brain activation during cognitive performance between ecstasy (3,4-methylenedioxymethamphetamine) users and control subjects: a [H2(15)O]-positron emission tomography study.

    abstract::The long-term use of the serotonin-releaser and uptake-inhibitor 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") has been associated with memory impairments and increased liability to depressive mood and anxiety attacks. It is unclear, however, whether these psychologic deviations are reflected in alterations of t...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/00004714-200102000-00012

    authors: Gamma A,Buck A,Berthold T,Vollenweider FX

    更新日期:2001-02-01 00:00:00

  • The drug-placebo response curve: a new method for assessing drug effects in clinical trials.

    abstract::Unlike many other areas of medicine, psychiatric clinical trials have no gold standard laboratory tests with which to measure drug effects. Although reliable and valid psychometric measures are available, the standard analysis of such measures obscures the clinical relevance of drug effects. In this study, the authors...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/00004714-200012000-00014

    authors: Faraone SV,Biederman J,Spencer TJ,Wilens TE

    更新日期:2000-12-01 00:00:00

  • Economic and health state utility determinations for schizophrenic patients treated with risperidone or haloperidol.

    abstract::The current study uses utility analysis to assess economic and quality-of-life benefits of risperidone in patients with chronic schizophrenia. A retrospective analysis was performed on Positive and Negative Syndrome Symptoms (PANSS) data obtained from the published Canadian multicenter risperidone trial (part of the N...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00004714-199708000-00010

    authors: Chouinard G,Albright PS

    更新日期:1997-08-01 00:00:00

  • Novel antipsychotics and severe hyperlipidemia.

    abstract::Newer atypical antipsychotics demonstrate superior effectiveness, with a diminished incidence of extrapyramidal side effects compared with older typical antipsychotics, but they have been associated with the development of obesity and new-onset diabetes. A small number of reports documenting modest hypertriglyceridemi...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/00004714-200108000-00003

    authors: Meyer JM

    更新日期:2001-08-01 00:00:00

  • Alprazolam treatment of postcoronary bypass anxiety and depression.

    abstract::The effectiveness of alprazolam in treating symptoms of anxiety and depression in 60 patients undergoing coronary bypass surgery was assessed in a double-blind, placebo-controlled study. The results indicate that alprazolam treatment for anxiety following coronary bypass surgery, particularly symptoms occurring in the...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Freeman AM 3rd,Fleece L,Folks DG,Sokol RS,Hall KR,Pacifico AD,McGiffin DC,Kirklin JK,Zorn GL,Karp RB

    更新日期:1986-02-01 00:00:00

  • Double-blind clinical trial of sertraline treatment for alcohol dependence.

    abstract::Clinical studies that have evaluated serotonergic medications to reduce alcohol consumption have yielded conflicting results. These studies primarily treated patients with alcohol dependence, excluding those with a current depressive disorder, in an effort to differentiate any medication effects directly on drinking f...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00004714-200104000-00005

    authors: Pettinati HM,Volpicelli JR,Luck G,Kranzler HR,Rukstalis MR,Cnaan A

    更新日期:2001-04-01 00:00:00

  • Predictors of treatment response in obsessive-compulsive disorder: multivariate analyses from a multicenter trial of clomipramine.

    abstract::There have been many attempts to find predictors of the therapeutic response to the clomipramine treatment of obsessive-compulsive disorder. The majority of studies have failed to identify such predictors. Possible reasons for this failure include the small sample size of most studies, samples homogeneous with respect...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:

    authors: Ackerman DL,Greenland S,Bystritsky A,Morgenstern H,Katz RJ

    更新日期:1994-08-01 00:00:00

  • Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    abstract::Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned i...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/JCP.0000000000000072

    authors: Jeon HJ,Woo JM,Lee SH,Kim EJ,Chung S,Ha JH,Fava M,Mischoulon D,Kim JH,Heo JY,Yu BH

    更新日期:2014-04-01 00:00:00

  • The impact of acamprosate on cue reactivity in alcohol dependent individuals: a functional magnetic resonance imaging study.

    abstract::Alcohol cue-induced brain activation has been studied extensively in alcoholics. However, little is known about the impact of standard treatment protocols on this phenomenon. The current study aimed at investigating the impact of the anticraving substance acamprosate on alcohol cue-related brain activity. Patients und...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0b013e318267b586

    authors: Langosch JM,Spiegelhalder K,Jahnke K,Feige B,Regen W,Kiemen A,Hennig J,Olbrich HM

    更新日期:2012-10-01 00:00:00

  • A Pilot Study of a Topical Intervention for Treatment of Female Sexual Dysfunction.

    abstract:PURPOSE/BACKGROUND:Many investigators reported that pharmacological treatment of female sexual dysfunction (FSD) has been a promising field yet to be explored. The purpose of this pilot study was to investigate the efficacy and safety of a topical cream containing small concentrations of three vasodilators with differe...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/JCP.0000000000000811

    authors: Gomaa AA,Abdel Aziz NM,Thabet RH,Fouly HA,Altellawy SH,Gomaa GA

    更新日期:2018-02-01 00:00:00

  • Antipsychotic Use and the Risk of Initiating Medication for Benign Prostate Hyperplasia in Persons With Alzheimer Disease: A Matched Cohort Study.

    abstract:BACKGROUND:Antipsychotics (APs) are known to exacerbate symptoms of benign prostate hyperplasia (BPH) and may even cause urinary retention. The anticholinergic effects of APs and their dopamine D2- and α-receptor blockade may lead to voiding dysfunction of BPH patients. The objective of our study was to investigate whe...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000000928

    authors: Orsel K,Taipale H,Raatikainen S,Lampela P,Tolppanen AM,Koponen M,Tanskanen A,Tiihonen J,Gardarsdottir H,Hartikainen S

    更新日期:2018-10-01 00:00:00

  • The Effect of Valproic Acid on Olanzapine Serum Concentration: A Study Including 2791 Patients Treated With Olanzapine Tablets or Long-Acting Injections.

    abstract:BACKGROUND:The combination of olanzapine and valproic acid (VPA) is regularly prescribed in the treatment of bipolar or schizoaffective disorders. The VPA has been shown to reduce olanzapine concentration, but the mechanism behind this interaction remains unknown. We aimed to investigate the effect of VPA on olanzapine...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000001126

    authors: Tveito M,Smith RL,Høiseth G,Molden E

    更新日期:2019-11-01 00:00:00

  • Therapeutic spectrum of nemonapride and its relationship with plasma concentrations of the drug and prolactin.

    abstract::The therapeutic spectrum of nemonapride, a new substituted benzamide, and its relationship with plasma concentrations of the drug and prolactin were investigated by a fixed-dose study (18 mg/day for 3 weeks) in 31 patients with acutely exacerbated schizophrenia. Of 31 patients, 25 (80.6%) were responders who showed a ...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/00004714-200008000-00003

    authors: Kondo T,Mihara K,Yasui N,Nagashima U,Ono S,Kaneko S,Ohkubo T,Osanai T,Sugawara K,Otani K

    更新日期:2000-08-01 00:00:00

  • Psychological strategies for discontinuing benzodiazepine treatment.

    abstract::Successful discontinuation of therapeutic drugs requires patients to negotiate two potentially difficult phases. First, they must complete the drug discontinuation procedure itself, which may entail coping with rebound and withdrawal symptoms as well as anxiety due to stopping a treatment on which they depend psycholo...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,评审

    doi:10.1097/00004714-199912002-00004

    authors: Spiegel DA

    更新日期:1999-12-01 00:00:00

  • Monthly Extended-Release Risperidone (RBP-7000) in the Treatment of Schizophrenia: Results From the Phase 3 Program.

    abstract:PURPOSE/BACKGROUND:The Phase 3 program for RBP-7000, a once-monthly subcutaneous (SC) extended-release risperidone formulation approved for treatment of schizophrenia, consisted of a double-blind placebo-controlled trial (previously reported) and a 52-week open-label study of monthly RBP-7000 120 mg. The primary object...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1097/JCP.0000000000001076

    authors: Andorn A,Graham J,Csernansky J,Newcomer JW,Shinde S,Muma G,Heidbreder C,Fava M

    更新日期:2019-09-01 00:00:00

  • Updates on Preclinical and Translational Neuroscience of Mood Disorders: A Brief Historical Focus on Ketamine for the Clinician.

    abstract:BACKGROUND:The development of new-generation antidepressants comes at a time of great clinical need when the global burden of depression, suicide, and other psychiatric conditions continues to increase. Our current treatment armamentarium is limited by the time delay needed for antidepressant effects and the significan...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000001132

    authors: Mischel NA,Kritzer MD,Patkar AA,Masand PS,Szabo ST

    更新日期:2019-11-01 00:00:00

  • Hospitalization resource utilization and costs among Medicaid insured patients with schizophrenia with different treatment durations of long-acting injectable antipsychotic therapy.

    abstract::This study evaluated the impact of using long-acting injectable (LAI) antipsychotics for a longer treatment duration versus a short duration on health care resource utilization among Medicaid-insured schizophrenia patients. Schizophrenia patients 13 years or older initiating LAI antipsychotics were identified from the...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0b013e3182a6082a

    authors: Bera R,Offord S,Zubek D,Lau G,Lin J,Karson C

    更新日期:2014-02-01 00:00:00

  • Concomitant use of acetylcholine esterase inhibitors and urinary antispasmodics among Finnish community-dwelling persons with Alzheimer disease.

    abstract::Concomitant use of acetylcholine esterase inhibitors (AChEIs) and anticholinergic drugs, such as urinary antispasmodics (UA), is generally considered as inappropriate because of their opposite pharmacological actions. However, prevalence and the duration or factors associated with concomitant use have not been previou...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000000218

    authors: Torvinen-Kiiskinen S,Taipale H,Tanskanen A,Tiihonen J,Hartikainen S

    更新日期:2014-12-01 00:00:00

  • Open-label pilot study of modafinil for methamphetamine dependence.

    abstract::Methamphetamine has become a major public health issue globally, particularly in the United States. Despite this, no effective pharmacotherapy for methamphetamine abuse has been developed to date. This 6-week, open-label pilot clinical trial examined the safety and tolerability of modafinil up to 400 mg/d in 8 methamp...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/JCP.0b013e3181b591e0

    authors: McGaugh J,Mancino MJ,Feldman Z,Chopra MP,Gentry WB,Cargile C,Oliveto A

    更新日期:2009-10-01 00:00:00

  • Mianserin pharmacokinetics and behavior in hyperkinetic children.

    abstract::The present study was conducted to derive pediatric mianserin pharmacokinetic parameters, which were compared to those from healthy young adults, and to obtain preliminary information regarding the utility of mianserin for the management of hyperkinesis in children. The sample consisted of six prepubescent children wi...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:

    authors: Winsberg BG,Camp-Bruno JA,Vink J,Timmer CJ,Sverd J

    更新日期:1987-06-01 00:00:00

  • Bupropion improves sexual functioning in depressed minority women: an open-label switch study.

    abstract::Minority women often have a unique set of beliefs and expectations about medical treatment. At this time, there is a dearth of research looking at how depressed minority women respond to pharmacological interventions for the sexual concomitants of depression. This was the first study to examine the impact of a medicat...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1097/01.jcp.0000194623.07611.90

    authors: Dobkin RD,Menza M,Marin H,Allen LA,Rousso R,Leiblum SR

    更新日期:2006-02-01 00:00:00

  • Fluoxetine and Risk of Bleeding in Patients Aged 60 Years and Older Using the Korea Adverse Event Reporting System Database: A Case/Noncase Study.

    abstract:BACKGROUND:Depression, the leading cause of nonfatal disease burden, has a strong correlation with suicide and affects approximately 7% of the general elderly population. Adverse drug reactions in older patients are particularly important because of reduced drug metabolism, polypharmacy, drug-drug interactions, and dru...

    journal_title:Journal of clinical psychopharmacology

    pub_type: 杂志文章

    doi:10.1097/JCP.0000000000001059

    authors: Kim S,Ko YJ,Park K,Yang BR,Kim MS,Park BJ

    更新日期:2019-07-01 00:00:00