TCT + AMPH for Schizophrenia

Clinical Teaching Facility (CTF-B102) at UCSD Medical Center, San Diego, CA
Schizophrenia+1 More ConditionsAMPH - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 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

Week 22
Change from baseline TCT weekly for 30 weeks, plus 2 post session tests

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

TCT + AMPH
1 of 2
TCT + PBO
1 of 2

Active Control

Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: TCT + AMPH · Has Placebo Group · Phase 2

TCT + PBO
Drug
PlaceboComparator Group · 1 Intervention: SHAM · Intervention Types: Drug
TCT + AMPH
Drug
ActiveComparator Group · 1 Intervention: AMPH · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,050 Previous Clinical Trials
1,827,305 Total Patients Enrolled
25 Trials studying Schizophrenia
5,747 Patients Enrolled for Schizophrenia
Neal R Serdlow, M.D., Ph.D.Principal InvestigatorUC San Diego

Eligibility Criteria

Age 18 - 55 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with schizophrenia or a type of schizophrenia that also causes depression.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.