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Effect of Action-Based Cognitive Remediation in Patients With Bipolar Disorder

NCT03295305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-03-04

No results posted yet for this study

Summary

PRETEC-ABC aims to assess the effect of a new form of cognitive remediation, Action-Based Cognitive Remediation (ABCR), in patients with bipolar disorder in remission on cognition, and to assess the neural assays for treatment effects with the purpose of identifying a neural biomarker for pro-cognitive effect. It is hypothesized (i) that ABCR vs. a control treatment has a beneficial effect on cognition in remitted patients with bipolar disorder remission. It is hypothesized (ii) that this treatment-associated improvement of cognition translates into better functional capacity at a six months follow-up assessment (secondary outcome). Finally, as an exploratory measure, it is hypothesized that ABCR will produce an early change in frontal activity and that this activity will correlate with ABCR-associated improvements in cognitive function.

Conditions

Interventions

BEHAVIORAL

Action-Based Cognitive Remediation

BEHAVIORAL

Unstructured support group

Sponsors & Collaborators

  • Lundbeck Foundation

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Kamilla W Miskowiak, Dr · Mental Health Services, Capital Region of Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-07-01
Completion
2020-01-25

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295305 on ClinicalTrials.gov