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PACT for Schizophrenia

Phase 2
Recruiting
Led By Neal R Serdlow, M.D., Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-IV diagnosis of schizophrenia or schizoaffective disorder, depressed type
Age 18 - 55
Must not have
Auditory or visual impairments severe enough to prevent study participation
Under conservatorship (determined by Anasazi)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial looks to see if a new way to treat chronic psychotic disorders, called Pharmacologic Augmentation of Cognitive Therapy (PACT), is more effective than the current standard treatment.

Who is the study for?
This trial is for English-speaking adults aged 18-55 with schizophrenia or schizoaffective disorder, who are not using recreational drugs and do not have dementia, mental retardation, severe sensory impairments, a history of traumatic brain injury, current substance abuse issues (unless sober for over 30 days), or under conservatorship.
What is being tested?
The study tests a new strategy called Pharmacologic Augmentation of Cognitive Therapy (PACT) to enhance cognitive training in psychosis. It involves comparing the effects of AMPH medication against SHAM (placebo) alongside targeted cognitive training sessions.
What are the potential side effects?
While specific side effects are not listed here, AMPH medications typically can cause nervousness, restlessness, headache, dizziness, insomnia among others. The placebo group should experience minimal to no side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia or schizoaffective disorder, depressed type.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe hearing or vision problems that would stop me from joining the study.
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I am under legal conservatorship.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline TCT weekly for 30 weeks, plus 2 post session tests

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TCT + AMPHActive Control1 Intervention
Group II: TCT + PBOPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,349 Total Patients Enrolled
27 Trials studying Schizophrenia
5,816 Patients Enrolled for Schizophrenia
Neal R Serdlow, M.D., Ph.D.Principal InvestigatorUC San Diego

Media Library

Pharmacologic Augmentation of Cognitive Therapy (PACT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04414930 — Phase 2
Schizophrenia Research Study Groups: TCT + PBO, TCT + AMPH
Schizophrenia Clinical Trial 2023: Pharmacologic Augmentation of Cognitive Therapy (PACT) Highlights & Side Effects. Trial Name: NCT04414930 — Phase 2
Pharmacologic Augmentation of Cognitive Therapy (PACT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04414930 — Phase 2
~14 spots leftby Sep 2025
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