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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,521,355 Total Patients Enrolled

27 Trials studying Schizophrenia

5,832 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants are engaging with this investigation?

"Affirmative. Records hosted on clinicaltrials.gov suggest that this research initiative, posted initialy in November 2020, is presently seeking volunteers. Approximately 70 people must be enlisted from a single medical facility."

Answered by AI

Are there any specific criteria for potential participants of this clinical research?

"To be eligible to partake in the trial, applicants must have schizophrenia and fall between 18-55 years of age. The study is attempting to recruit a total of 70 individuals."

Answered by AI

What can be said regarding the safety of TCT + AMPH treatments for patients?

"The current level of safety data surrounding TCT + AMPH has earned it a score of 2. This is because the trial currently in progress is only Phase 2, demonstrating some evidence for its security but not yet its efficacy."

Answered by AI

Do the parameters of this trial include individuals over forty years old?

"This investigation is only open to participants aged 18-55. However, there are 94 studies specifically aimed at those below the age of consent and 210 for seniors over 65 years old."

Answered by AI

Is enrollment still open for this research trial?

"Yes, according to clinicaltrials.gov, this medical trial is actively seeking participants. Initially shared on November 9th 2020 and most recently updated on June 2nd 2022, the study expects to recruit 70 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

Neal R. Swerdlow, M.D., Ph.D. 2020. "Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04414930.

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