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Institutional Review Board New York State Psychiatric Institute Institutional Review Board February 08, 2019 To: Dr. Bret Rutherford From: Dr. Edward Nunes, IRB Co-Chair Dr. Agnes Whitaker, IRB Co-Chair Subject: Approval Notice: Continuation Expedited per 45CFR46.110(b)(1)(f)(8c) Your protocol # 7270 entitled: A STUDY OF L-DOPA FOR DEPRESSION AND SLOWING IN OLDER ADULTS Protocol version date 02/08/2019 has been approved by the New York State Psychiatric Institute - Columbia University Department of Psychiatry Institutional Review Board from March 07, 2019 to March 06, 2020. Consent requirements: √ Not applicable: Data Analysis Only 45CFR46.116 (d) waiver of consent Signature by the person(s) obtaining consent is required to document the consent process Documentation of an independent assessment of the participant’s capacity to consent is also required. Approved for recruitment of subjects who lack capacity to consent: No Yes Field Monitoring Requirements: Routine Special: ___________________ Only copies of consent documents that are currently approved by the IRB may be used to obtain consent for participation in this study. A progress report and application for continuing review is required 2 months prior to the expiration date of IRB approval. Changes to this research may not be initiated without the review and approval of the IRB except when necessary to eliminate immediate hazards to participants. All serious and/or unanticipated problems or events involving risks to subjects or others must be reported immediately to the IRB. Please refer to the PI-IRB website at http://irb.nyspi.org for Adverse Event Reporting Procedures and additional reporting requirements. Cc: RFMH Business Office (NIMH R61 MH110029; CU Subcontract) EN/AHW/alw Signed copy on file at IRB v. 11/15/13 Protocol Summary Form 7270 Rutherford, Bret Protocol Title: Version Date: A Study of L-DOPA for Depression and 02/08/2019 Slowing in Older Adults Protocol Number: 7270 First Approval: Clinic: 03/10/2016 Adult and Late Life Depression Expiration Date: 03/06/2020 Contact Principal Investigator: Co-Investigator(s): Bret Rutherford, MD Patrick Brown, PHD Email: [email protected] Telephone: 646 774 8660 Research Chief: Davangere Devanand, MD Cover Sheet Choose ONE option from the following that is applicable to your study If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no longer required, this option remains for historical purposes. I am submitting an annual continuation without modifications Division & Personnel Division What Division/Department does the PI belong to? Psychiatry Within the division/department, what Center or group are you affiliated with, if any? program on healthy aging and late life brain disorders Unaffiliated Personnel List investigators, if any, who will be participating in this protocol but are not affiliated with New York State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation. Dr. Anissa Abi-Dargham (SUNY Stony Brook) Page 1 of 43 Protocol Summary Form 7270 Rutherford, Bret Dr. Mark Slifstein (SUNY Stony Brook) Application for Continuation of Research Status Current Status of Study: All research interventions were completed. Only data analysis is ongoing. Summary of Experiences to Date Please provide a summary of scientific progress of the study and the experience of research participants, to date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and benefits in terms of developments in the field, changing practice patterns, and new IRB policies and procedures. 36 subjects participated who were 75.3 ± 7.5 years old and 44.4% male. Significant, dose dependent increases in processing and gait speed were observed with L-DOPA (450mg dose: processing speed factor score effect size [ES] = 0.41, p = 0.001; dual task gait speed ES = 0.43, p = 0.003). [11C]raclopride ∆BPND was significantly different from 0 in sensorimotor (t = -4.85, df = 24, p < 0.001) and associative striatum (t = -2.52, df 24, p = 0.019) but not in limbic striatum (t = 0.265, df = 24, p = 0.793). Depressive symptoms decreased significantly on the Hamilton Rating Scale for Depression (ES = -0.4, p = 0.01). Drop-out rate was 8.3%, and nausea was the most frequently-reported side effect. By enhancing availability of dopamine, L-DOPA improved processing and gait speed in depressed older adults and significantly decreased [11C]raclopride binding in selected striatal subregions. Funding Have there been any changes in funding status since the prior approval? No Have the principal investigator and other investigators made all required disclosures of financial interest in the study sponsor/product? Yes Summary Have there been any study findings, recent literature, or untoward events occuring here or at other sites in the past year which might affect the analysis of the safety, risks or benefits of study participation? No Have there been any serious adverse events (serious and/or unanticipated problems involving risks to subjects or others at this site which occured in the past year)? Yes Please describe them and indicate resultant protocol modifications made. Patient #30. SAE reported to IRB on 3/14/2018. We have attached the SAE report to this submission. Page 2 of 43 Protocol Summary Form 7270 Rutherford, Bret Protocol was modified as follows: we revised PET scan day procedures such that a research staff person will stay with the subject at all times throughout the procedure and during transportation to and from the PET Center. Have all study staff with a significant role in the design or implementation of the human subject components of this study received required training in human research subject protections? Yes Is the study covered by a certificate of confidentiality? No Overall Progress Approved sample size 60 Total number of participants enrolled to date 47 Number of participants who have completed the study to date 33 Have there been any significant deviations from the anticipated study recruitment, retention or completion estimates? No Comments / additional information Overall Participant Drop-out Summary/Circumstances of Discontinuation: Eleven (11) participants dropped out prior to taking any study medication: - Nine (9) participants dropped out after initial evaluation/signing study consent and were lost to follow-up; study staff was unable to reach them. - Two (2) participants dropped out due to previously existing health conditions; One (1) the PMD did not approve participation in the study; One (1) was scheduled for back surgery and no longer wished to participate. Three (3) participants dropped out after beginning clinical trial: - Two (2) participants dropped out at/prior to week two of the study due to medication intolerance (mild nausea and drowsiness) - One (1) participants dropped out at week two of the study due to flare up of previously existing, chronic health condition. Participant was cleared by PMD to remain in the study but did not wish to continue. Total of fourteen (14) participant drop-outs Sample Demographics Specify population Adults aged >60 years Total number of participants enrolled from this population to date 47 Page 3 of 43 Protocol Summary Form 7270 Rutherford, Bret Gender, Racial and Ethnic Breakdown Male: 17 Female: 30 White: 26 African American: 17 Asian: 1 Other: 3 Hispanic: 8 Non-Hispanic: 39 Summary of Current Year's Enrollment and Drop-out Number of participants who signed consent in the past year 14 Did the investigator withdraw participants from the study? No Did participants decide to discontinue study involvement? Yes Circumstances of discontinuation: Three (3) participants dropped out prior to taking any study medication: - Two (2) participants dropped out after initial evaluation/signing study consent and were lost to follow-up; study staff was unable to reach them. - One (1) participant dropped out due to previously existing health conditions; PMD did not approve participation in the study One (1) participant dropped out after beginning clinical trial: - One (1) dropped out at week two of the study due to flare up of previously existing, chronic health condition. Was cleared by PMD to remain in the study but participant did not wish to continue. Total of four (4) participant drop-outs in the past year Procedures To create the protocol summary form, first indicate if this research will include any of the following procedures Psychiatric Assessment Neuropsychological Evaluation Page 4 of 43 Protocol Summary Form 7270 Rutherford, Bret PET/SPECT Scan MRI Off-label Use of Drug or Device Population Indicate which of the following populations will be included in this research Adults over 50 Research Support/Funding Will an existing internal account be used to support the project? No Is the project externally funded or is external funding planned? Yes Select the number of external sources of funding that will be applicable to this study Funding Source #1 Is the PI of the grant/contract the same as the PI of the IRB protocol? Yes Select one of the following The grant/contract application is a pending review or a funding decision Source of Funding Federal Institute/Agency NIMH Grant Name Targeting Dopaminergic Mechanisms of Slowing to Improve Late Life Depression Grant Number R61 MH110029 Select one of the following Single Site Business Office RFMH Does the grant/contract involve a subcontract? Yes Subcontracted? To Name institution(s) Columbia University Page 5 of 43 Protocol Summary Form 7270 Rutherford, Bret Study Location Indicate if the research is/will be conducted at any of the following NYSPI This protocol describes research conducted by the PI at other facilities/locations No Lay Summary of Proposed Research Lay Summary of Proposed Research Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD.
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