Author Archive

Nomenclature and Classification SIB Sub-Group

Monday, June 1st, 2015

Nomenclature and Classification Issues Bibliography

Working Group Goal:
Review status and develop consensus on the principles and characteristics of a standardized nomenclature and classification scheme for SIB

Possible Activities:

–Clarify difference(s) between a nomenclature and a classification system

–Establish underlying principles and characteristics for a standardized nomenclature for SIB 

–Commonly understood terms which are (1) linked to unambiguous definitions and (2) mutually exclusive.

–Logical, conceptual structure relating individual terms

–Clinically meaningful phenotypic classifications of suicide ideation and risk (eg, imminent vs longer term, acuity vs chronicity, passive vs active)

–Widely acceptable, comprehensible, practicable, simple, unambiguous, parsimonious

–Applicable to multiple domains and regions (public health, research, clinical practice)

–Able to be operationalized and validated through field testing (Silverman et al 2007)

–Underlying principles and characteristics of a classification scheme for SIB

–Establish a bibliography and review existing recommendations for establishing classification systems (eg, Best Practice Guidelines for Developing International Statistical Classifications   (UN Dept of Economic and Social Affairs, Statistical Division, 2011)

–Review existing SIB classification systems in light of these recommendation

–Recommend an optimal SIB classification scheme

Sub-group members

Greg Brown, University of Pennsylvania
Lisa Brenner, Denver VA Medical Center
Phillip Chappell, Pfizer
Diego De Leo, Australian Institute for Suicide
Suresh Durgam, Forest
Rob Goldman, Sunovion
Susan Kozauer, Quintiles
Shane McInerney, University Health Network, Toronto
Kelly Posner, Columbia University
John Rush, Duke
David Sheehan, University of South Florida
Morton Silverman, Suicide Prevention Resource Center
Leonardo Tondo, McLean Hospital, Harvard Medical School

Nomenclature and Classification Issues Working Group Internal Documents

Announcing Consensus Meeting on Methodological Considerations for Suicide Assessment and Clinical Trial Design

Friday, May 29th, 2015

17-18 November 2015
The Ritz-Carlton – Pentagon City
Arlington, VA (minutes from Reagan International Airport)
Meeting is open to all – Registration to open 3 August 2015*

Steering Committee:
Phillip Chappell
Michelle Stewart
Larry Alphs
Stephen Marder

Objective: (more…)

Challenges in Utilizing Outcome Measures Across Regions and Cultures

Sunday, March 15th, 2015

Chairs: Richard Keefe, Stefan Leucht

CNS drug development has become internationally driven and implemented. As a result, new scientific, regulatory, cultural, and operational complexities need to be considered for successful outcomes. This session will engage speakers with broad experience in international clinical trials.   They will discuss typical approaches and recent advances for harmonizing key outcome measures across countries, languages and cultures in order to improve signal intensity in international clinical trials.  Speakers will describe their experience with large multinational trials in schizophrenia and bipolar disorder, and will report on the progress of the ISCTM working group on harmonization of key outcome measures.  Representatives from regulatory agencies in Europe will comment on the regulatory perspective on the implementation of translated outcome measures in clinical trials. 

Continued Challenges with Placebo Response in CNS Trials: What Has Changed and What Have We Learned in Mood Disorders, Schizophrenia and Pain

Friday, March 13th, 2015

Chairs: Steven Romano, Geert Groeneveld

The placebo response in CNS treatment trials is notoriously high and efforts to identify and exclude “placebo responders” from CNS trials have had limited impact. Suggestion of efficacy has been shown to lead to improvement of symptoms of pain and depression and can therefore seriously influence trials and can even lead to failure in the development of novel analgesics and anti-depressants. This session will focus on the impact of the placebo response on trials in the CNS field as well as discuss the neurobiological background of the placebo effect.

Cognitive Impairment in Major Depressive Disorder as a Target for Drug Development

Thursday, March 12th, 2015

Chairs: Thomas Laughren, Catherine Harmer

This session will cover the scientific basis for considering CI in MDD as an unmet need and legitimate entity for drug development, and also important methodological issues such as optimal assessment approaches, study design, and when in the illness to study CI.  Also provided will be an industry perspective from a representative of a company that has approached this target, and also regulatory perspectives.  

An Update on Critical Issues for Alzheimer’s Disease

Thursday, March 12th, 2015

Chairs: R Anand, G Knudsen

Over 25 years have elapsed since the first approval for a New Chemical Entity (NCE) based on a neurotransmitter approach to treat the symptoms of Alzheimer’sDisease (AD).  Since that time four new treatments, also based on neurotransmitter approaches (e.g. cholinesterase inhibition, NMDA receptor blockade), have been introduced for AD patients; however, their effects have been modest, of relatively short duration, and without any impact on the course of the disease. These benefits have been achieved by agents whose daily treatment costs are affordable for most patients and society. Some of these agents have also been approved for the treatment of other neurodegenerative dementias. 

Neuropathologic and biopsy findings of beta amyloid containing plaques, a by-product of the faulty cleavage of the Amyloid Precursor Protein (APP) in the brains of AD patients, has led to efforts to develop treatments that reduce beta amyloid in the brain by reducing its synthesis, preventing its deposition in the plaque by inhibiting its aggregation, promoting plaque breakdown and its sequestration in the periphery, and increasing its clearance.

Results from multinational trials of up to 2 years in patients with mild to moderate AD to date have failed to demonstrate any statistically significant, or clinically relevant benefit on any of the key measures of cognition, activities of daily living, brain atrophy or relevant bio-markers in a priori-defined statistical analyses.  Although post hoc analyses in smaller subsets of patients indicate larger benefits in milder patients, and suggest the need to evaluate prodromal AD patients as a potential target population, no results are available in prodromal patients.   

Recent initiatives in collecting neuroimaging, psychometric, and clinical data, in conjunction with biochemical investigations of CSF markers, in a population at risk for dementias indicate that the structural and functional changes are already evident 5-10 years before the diagnosis of AD. Clinical and pathological investigations have indicated that the onset of clinical symptoms of AD predate the clinical diagnosis by approximately 3-5 years. Findings from follow-up studies in patients with genetic forms of AD, e.g. presenilin 1 mutations, indicate that clinical deterioration may start almost a decade prior to diagnosis, while changes in bio-markers, such as CSF aβ -42 and Tau, as well as subtle cognitive changes may occur well more than a decade prior to clinical signs.

It has been established that AD pathological changes originate in the entorhinal cortex and progress along synaptically connected circuits to involve the hippocampus, followed by other neocortical areas. The same mechanism of spread of Tau has been demonstrated for other degenerative dementias. It is not surprising that therapeutic strategies that have been pursued in AD and other dementias have failed to arrest or modify the progression of the disease, as the current paradigm involves testing patients with a clinical diagnosis, which represent stages where extensive brain changes have already occurred and cannot be reversed.

Perhaps, due to the emphasis on developing treatments for early AD patients, very little effort has been expended for developing treatments that would reduce the suffering of patients with moderate and severe dementia, despite evidence that these patients are living longer and are a source of concern for families and governments. There is a need to re-balance the focus in research to use scanty vital resources, not only on high-risk therapies for patients at risk for dementias, but also the millions with established disease.

The development of disease progression therapies has been difficult, expensive, and time-consuming, involving major sacrifices from patients and their caregivers. The likely cost of these treatments will most certainly be multiples of the cost of currently available symptomatic treatments for a benefit that appears elusive, and will not be used for patients whose disease state is more than mild. It is time to re-initiate neuro-chemical research for symptomatic treatments that may alleviate the impairments in cognition, behavior and function in mild to severe AD patients.

This session will bring together an international faculty of researchers from the fields of basic research, genetics and neuro-imaging, experts in public policy and regulatory affairs, and clinicians to evaluate the current status of progress and establish new priorities for AD research and development of effective treatments.

ISCTM Poster Guidelines-Amsterdam

Tuesday, January 27th, 2015

ISCTM Guidelines for submission and preparation of Poster (Link to submission form at bottom of this page)
The goals of the ISCTM, which emphasize methodological analyses, strategies, and applications in clinical trials in CNS disorders, result in challenges and some differences in priorities from those commonly occurring in most scientific organizations which include CNS disorders in their organizational aims.  The ISCTM is more likely to have memberships from corporations which have methodological capabilities as a focus of their corporate activities.  Such commercial interests are fully justifiable. Within the structure of the ISCTM, our policies, listed below, are intended to avoid any practice which is promotional of, or could be perceived as promotional of an individual’s or firm’s commercial interests.

TITLE: The title of a presentation and or abstract should be free of commercial information.  The number of characters, inclusive of spaces, should not exceed 130.

LOGOS and ACADEMIC SEALS: Logos and seals should be limited to ones which are not intended for, or could be interpreted as promoting commercial interests.  The size of logos should not be dominant and may only appear at the bottom of the poster.

AUTHORS AND AFFILIATIONS:  List authors names without degrees.  Include initials without periods (e.g. Abrams, BC). Affiliations of authors should be noted by superscripts in author lines, and detailed in smaller font below the author lines.

SUBMISSION DEADLINE AND NOTIFICATION:  Abstract submission deadline – Wednesday, 15 July 2015.  Notifications will be sent no later than Monday, 27 July 2015.

QUALIFICATIONS FOR AUTHORSHIP: Those listed as authors must have contributed to each of these areas: Conception and design, data analysis and interpretation, drafting or revision of the poster.  In addition, each author must approve the final version of the poster.  For clinical studies, this policy will generally result in authorship both by investigators not affiliated with a sponsor as well as scientific personnel of the sponsoring organization(s).

FORMAT AND LENGTH:

Abstract
-Organize the abstract with the following sections:

-Word limit, exclusive of title, authors and references sections, should be less than 500 words. We recommend no references or figures for abstracts. However short tables and up to 2 references, sufficient to locate the article, may be included.

Poster:
-Posters are Vertical, not to exceed 95 cm (3’1″) horizontal and 140 cm (4′ 7″) vertical
-To insure easy viewing of the poster, please use font size of 16 or greater for all sections except references, Table/Figure legends and superscripts for references (which may be smaller font size but should still be easily viewable).
-Narratives in all sections of the poster should refrain from statements that could be perceived as promotional or seeking commercial advantage.  As example, “Treatment X represents a new efficacious and well tolerated first line treatment for early Alzheimer’s disease” would go beyond the conclusions possible from a single clinical trial.  Additionally, words or phrases which have been patented should be avoided.
-QR Code linking to electronic version of poster is permissible.

*Disclosure: A concluding Acknowledgment should be made regarding source of support and any individuals or organizations who aided a body of work.  Along with this statement each poster shall include one of the following statements along the bottom of the poster.  If the second option is applicable, then disclosure must be included as part of the abstract.
1. “The authors report no conflicts of interest for this work” or
2. “One or more authors report potential conflicts which are described in the program”

The Scientific Program Committee appreciates very much your cooperation in complying with these guidelines.

 SUBMIT POSTER

2015 Autumn Conference – Poster Submission Details and Guidelines

Tuesday, January 27th, 2015

ISCTM 2015 Autumn Conference
27-29 August 2015
Amsterdam Marriott Hotel
Amsterdam, The Netherlands

IT IS IMPORTANT THAT YOU REVIEW GUIDELINES.

The ISCTM Poster Committee is calling for Abstracts with content pertaining to significant CNS methodological problems-solutions relevant to the meeting program topics or previous ISCTM topics. ABSTRACTS AND POSTERS MUST BE FREE OF COMMERCIAL BIAS OR PROMOTION. (Please see Guidelines)

Submission Process: You may submit your Abstract online by filling out the form provided below or by EMAIL. If submitting by email, please be sure to include all requested information. You will receive a confirmation of receipt.

Submission Deadlines: Abstracts should be submitted no later than Wednesday, 15 July 2015  for review by the ISCTM Poster Committee.

Notification: You will be notified of the committee’s decision on or before Wednesday, 22 July 2015.

Meeting Dates: 27-29 August 2015

Formal poster session: Friday, 28 August 2015
Presenter must register for the meeting and attend the formal session. Poster session is part of the Scientific Program. ISCTM recommends that the poster be presented by the first author.  If that is not possible, please designate which author will be present at the session to discuss the work with attendees.

Poster set up: Friday, 28 August 2015,  12:00-14:00.  Poster order (board number) will be included in the Poster Abstract section of the Meeting Program booklet. Numbers will not be distributed prior to the meeting.

Poster removal: Posters should be removed at the conclusion of the formal Poster Session.

Location: The Marriott Amsterdam, Studio 4,5,6,7

Poster Review: Certificates of Recognition will be awarded.  In order to facilitate judging, please forward .pdf of poster to Secretariat for review by judging committee by Friday, 26 September.  Posters of awardees will be published on the ISCTM website.

Poster Dimensions: Posters are Vertical, not to exceed 4’ (122 cm) Horizontal by 6’ (183 cm) Vertical -Awaiting details
As the poster session is small, it is not necessary to include the presentation number on your poster.
(Refer to Guidelines link above for additional formatting information)

Shipping Information: 
Amsterdam Marriott Hotel
Stadhouderskade 12
1054 ES Amsterdam, The Netherlands
Attention: Guest- Receiver’s Name
Guest’s arrival date at hotel

ABSTRACT SUBMISSION FORM
Submission should contain:

  1. Title, all authors, author affiliations
  2. Methodological Question being addressed
  3. Abstract content should be formatted into sections as outlined in the Guidelines, with word count up to 500 exclusive of title, authors, affiliations.
  4. Please review Guidelines before submitting abstract.

If you are submitting abstract on behalf of author, please be sure to enter your name and email under Submitter.  Thank you.

2016 Autumn Conference – Speaker Online Confirmation and Agreement

Wednesday, December 17th, 2014

2015 Autumn Conference – Speakers’ Corner

Wednesday, December 17th, 2014

Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 2015 ‘Autumn’ Conference, which includes a Joint Day with ECNP. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning. 

Dates/Location
27-29 August 2015
Amsterdam Marriott
Amsterdam, The Netherlands
(Housing to be booked through the ISCTM.  Do not contact the hotel directly.
Details below)

STEP 1:  Complete the Online Confirmation and Agreement

STEP 2: Please Upload or Email Biographical Paragraph
(View Confirmed Presenters page)

2500 characters max (including spaces)

STEP 3: Register for the Meeting

You may access the fee-waived Speaker Registration path by using above link and on the Identity Confirmation page, using the email address where you receive ISCTM mail.  You will have the opportunity to book your housing during the registration process. Do not contact the hotel.

STEP 4: Please Upload or Email  Abstract

Abstract, for inclusion in the program book, should be submitted after the session development call with chairs (no later than Monday 15 June). Abstract should be in paragraph form,
< 300 words and contain no tables.

STEP 5:  Presentation Submission Schedule

— Draft: Chairs will advise according to each segment’s agenda development telecon schedule.
— Final: Bring flash drive to onsite registration desk the morning of your session, no later than 30 minutes prior to the start of the meeting day.

STEP 6:  Chairs/Co-Chairs – Publication Information

To facilitate timely dissemination of information discussed during ISCTM meetings, the ISCTM provides a Publication Liaison for each session and workshop.  The assigned liaisons will reach out to session chairs prior to the meeting.  The liaison role is initially to support the development of the Session Summary for posting to the ISCTM website, however the liaison is also available to support further publications resulting from the session as needed. (Output category specifications)

Timeline for Session Summary development: (TBD)

Travel Arrangements:
In order to meet ISCTM’s fiscal responsibilities, the Society endeavors to operate its meetings as close to break even as possible, hopefully in the black. The Executive does not wish to raise additional revenue through increasing registration fees, so we must keep a close watch on expenses.  Therefore, we ask speakers who will request reimbursement to keep this in mind when arranging travel, specifically, if at all possible, to book flights enough ahead of travel dates to take advantage of the lower fares. (2015 Autumn Reimbursement Policy)

Agenda at a Glance:

Day 1: Thursday, 27 August 2015
16:00-19:30  Onsite Registration Open
18:30- 20:00 Welcome Cocktail Reception

Day 2: Friday, 28 August 2015 – Joint Day with ECNP
7:30 Registration Opens / Continental Breakfast
8:30 – 10:30  Challenges in Utilizing Outcome Measures Across Regions and Cultures (Keefe/Leucht)
10:45-12:15  Cognitive Impairment in Major Depressive Disorder as a Target for Drug Development (Laughren/Harmer)
12:30-13:45 Lunch
13:45 -17:15 An Update on Critical Issues for Alzheimer’s Disease (Anand/Knudsen)     
17:30  Joint Sessions Adjourn
13:30-19:30 Reception/Poster Session

Day 3: Saturday, 29 August 2015
7:30   Registration Opens / Continental Breakfast
8:30   Placebo Response Challenges Across CNS Trials (Romano/Groeneveld)
13:15 Meeting Adjourns

ISCTM Contact Information

Thomas Laughren – Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Executive Assistant, ISCTM

Phone:  +1.615.383.7688