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Article ; Online: Do Not Rule Out Double-blind Placebo Run-in Periods for Randomized Clinical Trials.

Targum, Steven D

2022 Volume 79, Issue 4, Page(s) 381

MeSH term(s)	Double-Blind Method ; Humans ; Randomized Controlled Trials as Topic ; Treatment Outcome
Language	English
Publishing date	2022-02-28
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2701203-7
ISSN	2168-6238 ; 2168-622X
ISSN (online)	2168-6238
ISSN	2168-622X
DOI	10.1001/jamapsychiatry.2022.0048
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Article ; Online: Early symptomatic improvement affects treatment outcome in a study of major depressive disorder.

Targum, Steven D

Journal of psychiatric research

2017 Volume 95, Page(s) 276–281

Abstract: Early symptomatic improvement immediately following randomization can affect signal detection in clinical trials. The impact of early improvement of the Montgomery-Asberg depression rating scale (MADRS) on eventual treatment outcome was examined in a 6- ... ...

Abstract	Early symptomatic improvement immediately following randomization can affect signal detection in clinical trials. The impact of early improvement of the Montgomery-Asberg depression rating scale (MADRS) on eventual treatment outcome was examined in a 6-week, double-blind, placebo-controlled trial of a putative antidepressant (CX157) versus placebo in depressed subjects with major depressive disorder (MDD) who had had an inadequate response to ongoing antidepressant treatment (NCT00739908). MADRS score changes within one week after randomization directly affected treatment outcome at the study endpoint (week 6). The response and remission rates at week 6 increased significantly as the percent of MADRS score improvement increased between baseline and week 1 regardless of treatment assignment. Less MADRS improvement or actual worsening within the first week after randomization was associated with minimal overall MADRS score changes by week 6 in either treatment assignment. Alternatively, CX157 assigned subjects who had ≥30% improvement by week 1 achieved a significantly greater treatment response rate than the matched placebo group at the study endpoint (p = 0.025) that converted the lack of signal detection in the mITT population. This post-hoc analysis highlights the potent effect that early symptomatic improvement immediately following randomization can have on treatment outcome, and is particularly relevant for antidepressant drugs with rapid onset of action. The findings compel further exploration of possible moderating and mediating factors, including the experimental condition itself that can influence early response, and the need to identify "bio-types" within the population of MDD subjects.
MeSH term(s)	Adult ; Antidepressive Agents/administration & dosage ; Antidepressive Agents/pharmacology ; Depressive Disorder, Major/drug therapy ; Heterocyclic Compounds/administration & dosage ; Heterocyclic Compounds/pharmacology ; Humans ; Outcome Assessment (Health Care)/standards ; Psychiatric Status Rating Scales ; Randomized Controlled Trials as Topic/standards ; Time Factors
Chemical Substances	Antidepressive Agents ; CX157 ; Heterocyclic Compounds
Language	English
Publishing date	2017-09-08
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3148-3
ISSN	1879-1379 ; 0022-3956
ISSN (online)	1879-1379
ISSN	0022-3956
DOI	10.1016/j.jpsychires.2017.09.009
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Article: Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants.

Yavorsky, Christian / Ballard, Elizabeth / Opler, Mark / Sedway, Jan / Targum, Steven D / Lenderking, William

Frontiers in psychiatry

2023 Volume 14, Page(s) 1135828

Abstract: ... within hours or days, rather than weeks or months. These novel targets include the N-methyl-D ...

Abstract	The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate receptor antagonist ketamine, along with its enantiomers and various derivatives, and the allosteric modulators of gamma-aminobutyric acid (GABA) receptors. There has also been a strong resurgence in interest in psychedelic compounds that impact a range of receptor sites including D1, 5-HT7, KOR, 5-HT5A, Sigma-1, NMDA, and BDNF. The RAADs developed from these novel targets have enabled successful treatment for difficult to treat depressed individuals and has generated a new wave of innovation in research and treatment. Despite the advances in the neurobiology and clinical treatment of mood disorders, we are still using rating instruments that were created decades ago for drugs from a different era (e.g., The Hamilton and Montgomery-Åsberg depression rating scales, HDRS, and MADRS) continue to be used. These rating instruments were designed to assess mood symptoms over a 7-day time frame. Consequently, the use of these rating instruments often requires modifications to address items that cannot be assessed in short time frames, such as the sleep and appetite items. This review describes the adaptative approaches that have been made with the existing scales to meet this need and examines additional domains such as daily activities, side effects, suicidal ideation and behavior, and role functioning. Recommendations for future studies are described, including the challenges related to implementation of these adapted measures and approaches to mitigation.
Language	English
Publishing date	2023-06-02
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2564218-2
ISSN	1664-0640
ISSN	1664-0640
DOI	10.3389/fpsyt.2023.1135828
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Article: The Effect of Early Life Stress on Adult Psychiatric Disorders.

Targum, Steven D / Nemeroff, Charles B

Innovations in clinical neuroscience

2019 Volume 16, Issue 1-2, Page(s) 35–37

Abstract: There is a crisis of early childhood maltreatment in the United States. In 2012, the United States Department of Health and Human Services noted 3.4 million referrals to childhood protective services, of which the majority related to child abuse or ... ...

Abstract	There is a crisis of early childhood maltreatment in the United States. In 2012, the United States Department of Health and Human Services noted 3.4 million referrals to childhood protective services, of which the majority related to child abuse or neglect. Early life stress (ELS) due to childhood abuse and/or neglect can generate life-long consequences. ELS has been associated with disrupted neurodevelopment that can yield social, emotional, and cognitive impairment; adult medical and psychiatric disorders; disability; and even earlier death. Some studies have shown that adults with major depression and ELS respond less well to conventional treatments than adults who did not experience early life stress. In this article, we review some of the neurobiological and epigenetic studies that explore this association.
Language	English
Publishing date	2019-04-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2675366-2
ISSN	2158-8341 ; 2158-8333
ISSN (online)	2158-8341
ISSN	2158-8333
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Article ; Online: Audio-digital recordings to assess ratings reliability in clinical trials of schizophrenia.

Targum, Steven D / Pendergrass, J Cara / Murphy, Christopher

Schizophrenia research

2021 Volume 232, Page(s) 54–60

Abstract: We examined ratings reliability in 5 clinical trials of subjects with schizophrenia experiencing an acute exacerbation of psychosis. Audio-digital recordings of site-based interviews of the Positive and Negative Syndrome Scale (PANSS) or Brief ... ...

Abstract	We examined ratings reliability in 5 clinical trials of subjects with schizophrenia experiencing an acute exacerbation of psychosis. Audio-digital recordings of site-based interviews of the Positive and Negative Syndrome Scale (PANSS) or Brief Psychiatric Rating Scale (BPRS) were used to obtain blinded, site-independent scores to evaluate paired scoring concordance. High intraclass correlations were noted between 1810 paired site-based and site-independent PANSS scores (r = 0.801) and 1837 paired BPRS scores (r = 0.897) with high limits of agreement such that 93.9% of paired scores were within the calculated 95% confidence intervals. In 2 studies where sufficient PANSS data was available at baseline and endpoint, blinded site-independent ratings yielded a predictive value of 84.2% for replicating site-based response/nonresponse treatment outcomes. There was a significant positive correlation between site-based scores and paired scoring deviations (PANSS: r = 0.246; p < 0.0001; BPRS: r = 0.176; p < 0.0001). The magnitude (symptom severity) of PANSS or BPRS scores affected the directionality of paired scoring deviations in each study. Site-based raters scored the most symptomatic subjects higher and less symptomatic subjects lower than the paired site-independent raters on either instrument. This analysis affirms the utility of paired audio-digital scoring of site-based interviews as a surveillance strategy for schizophrenia studies. We noted a high predictive value of blinded site-independent raters to replicate site-based treatment outcomes. The bi-directionality of paired scoring deviations observed for both the PANSS and BPRS is consistent with findings found for depression rating instruments.
MeSH term(s)	Antipsychotic Agents/therapeutic use ; Brief Psychiatric Rating Scale ; Humans ; Psychiatric Status Rating Scales ; Psychotic Disorders/diagnosis ; Psychotic Disorders/drug therapy ; Reproducibility of Results ; Schizophrenia/diagnosis ; Schizophrenia/drug therapy
Chemical Substances	Antipsychotic Agents
Language	English
Publishing date	2021-05-17
Publishing country	Netherlands
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639422-x
ISSN	1573-2509 ; 0920-9964
ISSN (online)	1573-2509
ISSN	0920-9964
DOI	10.1016/j.schres.2021.05.004
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Article ; Online: Audio-digital recordings for surveillance in clinical trials of major depressive disorder.

Targum, Steven D / Catania, Christopher J

Contemporary clinical trials communications

2019 Volume 14, Page(s) 100317

Abstract: Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of ... ...

Abstract	Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of paired scoring concordance and interview quality. We examined the utility of this surveillance strategy using paired site-independent scores derived from recorded site-based Montgomery-Asberg depression rating scale (MADRS) interviews obtained from patients with major depressive disorder (MDD) participating in 5 clinical trials. High correlations were noted between the 3736 paired site-based and site-independent scores across all visits. Some rater "outliers" were identified whose ratings performance improved following remediation. In 3 studies with available outcome data, the blinded remote ratings yielded a high predictive value (91.2%) for replicating treatment response rates. The magnitude of the total MADRS scores affected the directionality of paired scoring deviations in each of the 5 studies. Across all visits, site-based raters scored the more severe MADRS scores (≥30) higher than site-independent raters and the less severe MADRS scores (<20) lower than site-independent raters. Individual MADRS items were similarly affected by the directionality of symptom severity. This analysis affirms the utility of audio-digital recording of site-based interviews as a surveillance strategy for quality assurance (monitoring and remediation). In addition, the high predictive value of blinded remote ratings to replicate site-based treatment outcomes may be useful to affirm primary site-based results when there is a potential of functional unblinding. The use of remote ratings as a primary measure beyond its utility for quality assurance needs further exploration.
Language	English
Publishing date	2019-01-08
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2019.100317
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Article: Identification and treatment of antidepressant tachyphylaxis.

Targum, Steven D

Innovations in clinical neuroscience

2013 Volume 11, Issue 3-4, Page(s) 24–28

Abstract: Antidepressant tachyphylaxis describes a condition in which a depressed patient loses a previously effective antidepressant treatment response despite staying on the same drug and dosage for maintenance treatment. It has been suggested that ... ...

Abstract	Antidepressant tachyphylaxis describes a condition in which a depressed patient loses a previously effective antidepressant treatment response despite staying on the same drug and dosage for maintenance treatment. It has been suggested that antidepressant tachyphylaxis is a form of relapse related to evolving drug tolerance, but it is also clear that there are other possible reasons for the loss of treatment response unrelated to tolerance, such as medication nonadherence. It has been reported that depressed patients with "true" antidepressant tachyphylaxis may be less responsive to new treatment interventions. Therefore, it is important to identify these patients as part of a comprehensive treatment planning process.
Language	English
Publishing date	2013-11-21
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2675366-2
ISSN	2158-8341 ; 2158-8333
ISSN (online)	2158-8341
ISSN	2158-8333
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Article ; Online: Site-independent confirmation of primary site-based PANSS ratings in a schizophrenia trial.

Targum, Steven D / Murphy, Christopher / Breier, Alan / Brannan, Stephen K

Journal of psychiatric research

2021 Volume 144, Page(s) 241–246

Abstract: Blinded, site-independent (remote) ratings from audio-digital recordings of site-based Positive and Negative Syndrome Scale (PANSS) interviews were obtained in a 5-week, randomized, double-blinded study assessing the safety, tolerability, and efficacy of ...

Abstract	Blinded, site-independent (remote) ratings from audio-digital recordings of site-based Positive and Negative Syndrome Scale (PANSS) interviews were obtained in a 5-week, randomized, double-blinded study assessing the safety, tolerability, and efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) in hospitalized adults with schizophrenia experiencing an acute exacerbation of psychosis (EMERGENT-1; ClinicalTrials.gov identifier: NCT3697252). The blinded site-independent raters had no knowledge of site location, study visit, drug vs. placebo assignment, or any treatment emergent adverse events (TEAEs). Concordance analyses of 561 paired site-based and site-independent PANSS ratings across all visits revealed a high correlation (ICC = 0.775). Paired scoring differences were positively correlated with the PANSS total score (Spearman's rho = 0.37, p < 0.0001). Paired PANSS scores were available from 148 subjects at both the baseline and end of study visits (KarXT = 72, Placebo = 76). Site-based PANSS total scores (primary aim) revealed a significantly greater improvement from baseline in the KarXT group compared to the placebo group (p < 0.0001). The blinded site-independent PANSS total scores derived from listening to and scoring the recorded site-based PANSS interviews replicated this finding (p < 0.001) and yielded an overall predictive value of 85.1% for matching the site-based response/non-response outcomes. TEAE's have the potential to "unblind" site-based ratings. In this study, the site-independent raters were blinded to TEAEs, affirmed the site-based PANSS ratings, and mitigated concerns about possible functional unblinding of site-based raters. This method of blinded assessment via audio-digital recordings may have utility for other studies concerned with ratings precision and/or functional unblinding.
MeSH term(s)	Adult ; Antipsychotic Agents/therapeutic use ; Double-Blind Method ; Humans ; Psychotic Disorders/drug therapy ; Schizophrenia/chemically induced ; Schizophrenia/drug therapy ; Treatment Outcome
Chemical Substances	Antipsychotic Agents
Language	English
Publishing date	2021-10-21
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3148-3
ISSN	1879-1379 ; 0022-3956
ISSN (online)	1879-1379
ISSN	0022-3956
DOI	10.1016/j.jpsychires.2021.10.027
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Article ; Online: D-Cycloserine Improves Difficult Discriminations in a Pattern Separation Task in Alzheimer's Disease Patients with Dementia.

Goetghebeur, Pascal J D / Wesnes, Keith A / Targum, Steven D

Journal of Alzheimer's disease : JAD

2019 Volume 69, Issue 2, Page(s) 377–383

Abstract: ... hoc analysis of two large unsuccessful AD clinical trials, we examined the effect of D-cycloserine ...

Abstract	Recent fMRI studies in human identified that pattern separation ability is associated with increased activity in the hippocampal dentate gyrus (DG), whereas no such DG changes are seen during pattern completion. Disruption to neurogenesis in the DG has been associated with Alzheimer's disease (AD). In a post-hoc analysis of two large unsuccessful AD clinical trials, we examined the effect of D-cycloserine (DCS) on a specific object pattern separation measure, a component of the picture recognition task from the Cognitive Drug Research (CDR) system. This task yields a measure of pattern separation and a measure of pattern completion. Study data were available for 756 AD patients with dementia, randomized to several doses of DCS. Data were available at week 2, 6, 14, and 26 for 732, 707, 653, and 559 patients, respectively. None of the DCS doses had a statistically significant benefit over placebo on pattern completion. However, the DCS 15 mg BID dose significantly increased accuracy over placebo on the pattern separation measure by 5.1%. Further, the magnitude of the benefit of DCS 15 mg BID over placebo was almost doubled relative to the whole study population in a subset of patients whose pattern separation scores were≥2 standard deviations poorer than the CDR norm of age-matched healthy individuals at baseline. These post-hoc analyses suggest a potential value of the pattern separation task for evaluating compounds promoting neurogenesis. Further, the use of a restrictive pattern separation eligibility criterion might facilitate signal detection.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/drug therapy ; Alzheimer Disease/psychology ; Antimetabolites/pharmacology ; Antimetabolites/therapeutic use ; Cycloserine/pharmacology ; Cycloserine/therapeutic use ; Dementia/drug therapy ; Dementia/psychology ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Pattern Recognition, Visual/drug effects ; Pattern Recognition, Visual/physiology ; Photic Stimulation/methods ; Psychomotor Performance/drug effects ; Psychomotor Performance/physiology
Chemical Substances	Antimetabolites ; Cycloserine (95IK5KI84Z)
Language	English
Publishing date	2019-04-08
Publishing country	Netherlands
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1440127-7
ISSN	1875-8908 ; 1387-2877
ISSN (online)	1875-8908
ISSN	1387-2877
DOI	10.3233/JAD-181094
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Article ; Online: Ecological momentary assessment as a measurement tool in depression trials.

Targum, Steven D / Sauder, Colin / Evans, Miriam / Saber, John N / Harvey, Philip D

Journal of psychiatric research

2021 Volume 136, Page(s) 256–264

Abstract: We used ecological momentary assessment (EMA) to track symptoms during a clinical trial. Thirty-six participants with major depressive disorder (MDD) and MADRS scores ≥20 were enrolled in a nonrandomized 6-week open-label trial of commercially available ... ...

Abstract	We used ecological momentary assessment (EMA) to track symptoms during a clinical trial. Thirty-six participants with major depressive disorder (MDD) and MADRS scores ≥20 were enrolled in a nonrandomized 6-week open-label trial of commercially available antidepressants. Twice daily, a mobile device prompted participants to self-report the 6 items of the HamD
MeSH term(s)	Antidepressive Agents/therapeutic use ; Depression ; Depressive Disorder, Major/diagnosis ; Depressive Disorder, Major/drug therapy ; Ecological Momentary Assessment ; Humans ; Self Report
Chemical Substances	Antidepressive Agents
Language	English
Publishing date	2021-02-14
Publishing country	England
Document type	Journal Article
ZDB-ID	3148-3
ISSN	1879-1379 ; 0022-3956
ISSN (online)	1879-1379
ISSN	0022-3956
DOI	10.1016/j.jpsychires.2021.02.012
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