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NCT04414930 · ClinicalTrials.gov registry record · Phase 2

Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

A Phase 2 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT04414930: Completed Phase 2 study, sponsored by University of California, San Diego.

NCT04414930 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04414930, a Phase 2 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG d-amphetamine

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2020-11-09
Est. Completion 2024-12-30
Phase Phase 2
University of California, San Diego

775 total trials

What the finished NCT04414930 record still lists

NCT04414930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04414930 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04414930 about?

NCT04414930 is a clinical study titled "Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia". 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, incl...

What is the current status of trial NCT04414930?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2020-11-09. Estimated completion is 2024-12-30.

What interventions are being tested in trial NCT04414930?

The interventions under investigation include: Placebo (DRUG), d-amphetamine (DRUG).

Who is sponsoring clinical trial NCT04414930?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04414930's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04414930, the US trial registry maintained by the National Library of Medicine. NCT04414930 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.