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Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

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ClinicalTrials.gov Identifier: NCT04414930
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Neal R. Swerdlow, M.D., Ph.D., University of California, San Diego

Brief Summary:
These studies look to conduct efficient pilot testing of a novel intervention strategy for chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic psychotic disorders, including schizophrenia, but do not significantly alter their course or real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved function and cognition in psychosis patients, including "bottom-up" sensory-based targeted cognitive training (TCT). While benefits of TCT are evident at the group level, almost half of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For patients and clinicians, the costs and logistical complexities associated with these time- and resource-intensive interventions can be prohibitive. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of TCT in schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: AMPH Drug: SHAM Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: TCT + PBO Drug: SHAM
Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.

Active Comparator: TCT + AMPH Drug: AMPH
Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.




Primary Outcome Measures :
  1. Change from baseline TCT weekly for 30 weeks, plus 2 post session tests [ Time Frame: screening session (week 1) followed by weekly sessions for 10 weeks, 3 times per week (weeks 2- ~12), and 2 post session tests after week 12 and after week 22 ]
    Sound Sweeps



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria include:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder, depressed type
  • Written informed consent to participate in the study
  • Age 18 - 55
  • Absence of dementia or mental retardation
  • Urine toxicology negative for recreational drugs
  • Fluent and literate in English (needed for completion of WIN and QuickSIN)

Exclusion criteria include:

  • Meets DSM-IV criteria for current substance abuse or dependence and has been substance abstinent for less than 30 days
  • A history of traumatic brain injury
  • Auditory or visual impairments severe enough to prevent study participation
  • Under conservatorship (determined by Anasazi)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414930


Contacts
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Contact: Jo Benrubi, B.A. 6195432314 eyeblinkstudy@ucsd.edu

Locations
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United States, California
Clinical Teaching Facility (CTF-B102) at UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Jo Talledo Benrubi, B.A.    619-543-3093    atalledo@ucsd.edu   
Principal Investigator: Neal R. Swerdlow, M.D., Ph.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Neal R Serdlow, M.D., Ph.D. UC San Diego
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Responsible Party: Neal R. Swerdlow, M.D., Ph.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04414930    
Other Study ID Numbers: R33MH123603-01 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders