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NCT01561859 · ClinicalTrials.gov registry record · NA

Brain Imaging, Cognitive Enhancement and Early Schizophrenia

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
102
Enrollment target

NCT01561859: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.

NCT01561859 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01561859, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
102 participants
Enrollment target

Study Summary

The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.

Primary Outcome

Aim #1: Confirm the neuroprotective effects of CET on frontal and temporal brain structure. Structural magnetic resonance imaging (MRI) assessments will be collected along with cognitive and functional outcome data at baseline, 9, and 18 months. It is hypothesized that patients treated with CET will demonstrate decreased loss of frontal and temporal gray matter relative to EST, and that this neuroprotection will be a mechanism of cognitive and functional improvement.

Interventions

  • BEHAVIORAL Cognitive Enhancement Therapy
  • BEHAVIORAL Enriched Supportive Therapy

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2012-06
Est. Completion 2018-06
Phase NA

What the finished NCT01561859 record still lists

NCT01561859 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

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

NCT01561859 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01561859 about?

NCT01561859 is a clinical study titled "Brain Imaging, Cognitive Enhancement and Early Schizophrenia". The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, ...

What is the current status of trial NCT01561859?

This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2012-06. Estimated completion is 2018-06.

What interventions are being tested in trial NCT01561859?

The interventions under investigation include: Cognitive Enhancement Therapy (BEHAVIORAL), Enriched Supportive Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT01561859?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01561859's enrollment target sits among peer trials

102 837th of 2000 higher than 1,161 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01561859, the US trial registry maintained by the National Library of Medicine. NCT01561859 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.