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Memory Flexibility Training, Psychoeducation

Phase 1

Major Depressive Disorder | Unknown | Psychiatry |Cognition Therapeutics, Inc.|Last Updated: Sep 11, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02371291Memory Flexibility Training for DepressionPHASE1 COMPLETED 60Jan 1, 2015Jan 1, 2017Sep 11, 20172 United Kingdom
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Study Endpoints
Primary Endpoints
Depressive Status
Three months after completion of the workbook
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Three months after completion of the workbook

Self report measure of depression symptoms

Secondary Endpoints
Depression free days
Three months after completion of the workbook
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Three months after completion of the workbook
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Memory Flexibility TrainingEXPERIMENTALThe MemFlex programme draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014), and was developed by clinical psychologists. MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training material is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks which are used throughout the workbook, and guides the participant in completion of these tasks. When understanding of the basic principles is satisfactory, the researcher assists the participant to set a schedule for completion of the workbook over the following four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress.
PsychoeducationPLACEBO_COMPARATORThe psychoeducation condition will also complete an initial face-to-face session. This session will cover the symptoms and causes of depression, and the workbook will be introduced. As in the MemFlex condition, the workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties with the workbook material. The workbook content will cover the presentation of depression and basic information on factors associated with depression, such as worry, procrastination, and sleep difficulties. Each session consists of information on psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The workbook was developed by clinical psychologists.
Interventions
NameTypeDescription
Memory Flexibility TrainingBEHAVIORALAs in experimental arm description.
PsychoeducationBEHAVIORALAs in experimental arm description.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996). * Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996) Exclusion Criteria: * SCID assessment indicates they are exper...

Countries:United Kingdom
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