CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
d-amphetamine +1 moredrug
Likely dose
d-amphetamine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04414930
NCT04414930Phase 2Completed

Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

University of California, San Diego·interventional·Posted Jun 4, 2020·Updated Dec 17, 2025

In Brief

A Phase 2 clinical trial evaluating d-amphetamine and Placebo for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartNov 9, 2020
Primary CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.1 years ago

Interventions

d-amphetaminedrug

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.

Placebodrug

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