Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

NCT04414930 | Completed Phase 2 Results FDA Drug

• 1 other identifier: R33MH123603-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• Primary Clinical Outcome PANSS Total Score (PANSSt)

  Positive \& Negative Symptom Scale total (PANSSt) PANSS Total Score is the primary clinical outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 10 weeks). The PANSS total score has a range 30-210, with higher scores indicating worse outcome.

  approximately 10 weeks

• Primary Functional Outcome WHODAS

  Primary World Health Organization Disability Schedule (WHODAS 2.0) Function will be assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline vs. post-TCT session 10, 20 and 30 (approximately 10 weeks). The WHODAS 2.0 has a range 12-60, with higher scores indicating worse outcome.

  approximately 10 weeks

• Primary Neurocognitive Outcome MCCB-C

  MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 10 weeks). The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores, which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome.

  approximately 10 weeks

Secondary Outcomes (5)

• Secondary Clinical Outcome Measure PANSSp

  approximately 10 weeks

• Secondary Clinical Outcome Measure PANSSn

  approximately 10 weeks

• Psychotic Symptoms PSYRATS Hallucinations

  approximately 10 weeks

• Manic Symptoms YMRS

  approximately 10 weeks

• Current Depressive Symptoms PHQ

  approximately 10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects complete 30 sessions of Targeted Cognitive Training (2-3 times per week), and receive placebo po 1 hour prior to each training.

Drug: Placebo

Active Drug

ACTIVE COMPARATOR

Subjects complete 30 sessions of Targeted Cognitive Training (2-3 times per week), and receive amphetamine 5 mg po 1 hour prior to each training.

Drug: d-amphetamine

Interventions

d-amphetamine DRUG

Subjects complete 30 sessions of Targeted Cognitive Training (2-3 times per week), and receive amphetamine 5 mg po 1 hour prior to each training.

Active Drug

Placebo DRUG

Subjects complete 30 sessions of Targeted Cognitive Training (2-3 times per week), and receive placebo po 1 hour prior to each training.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Clinical Teaching Facility (CTF-B102) at UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Neal R. Swerdlow, M.D., Ph.D.
• Organization: UCSD

nswerdlow@health.ucsd.edu

6194719455

Study Officials

• Neal R Serdlow, M.D., Ph.D.

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: November 9, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-09

Locations

US (1)