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Effect of Action-Based Cognitive Remediation in Patients With Bipolar Disorder (PRETEC-ABC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295305
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Kamilla Woznica Miskowiak, Mental Health Services in the Capital Region, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Cognitive Impairment Behavioral: Action-Based Cognitive Remediation Behavioral: Unstructured support group Not Applicable

Detailed Description:

The trial will include outpatients with BD in full or partial remission (a score ≤14 on the Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS). Recruitment will be carried out through the ongoing Bipolar Illness Onset (BIO) study, the Copenhagen Affective Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, other mental health centres, consultant psychiatrists in the Capital Region of Denmark, and through advertisements on relevant websites.

Participants will undergo an eligibility assessment followed by randomisation. When 4 - 6 participants have been randomised to either the ABCR or the control group, the baseline assessments are carried out. The baseline assessment is completed over two days, 1 - 3 days apart. A fMRI scan is carried out on day 1 encompassing spatial and verbal working memory N-back tasks, a picture encoding task, a resting state and a structural scan. On day 2, a blood sample is drawn in the morning, followed by administration of a comprehensive neuropsychological test battery. Participants fill in questionnaires concerning subjective cognitive complaints, psychosocial functioning and quality of life and functional capacity is assessed using a clinician-rated interview and a performance based assessment. Sleep quantity and quality in the past three days is assessed. After two weeks of ABCR or control treatment, functional MRI, neuropsychological testing an assessment of mood and subjective cognition are repeated. These assessments, as well as assessments of functional capacity and quality of life, are repeated within two weeks after treatment completion and six months after treatment completion.

Block randomisation is carried out by Pharma Consulting Group, stratified by gender and age (patients < or ≥ 35 years).

Power calculation was also carried out by Pharma Consulting Group based on findings from a previous RCT in our group assessing the effect of 8 weeks of EPO treatment on the same cognitive composite score. In PreTEC-ABC, a clinically relevant difference between the ABCR and the control groups following 10 weeks of treatment is assumed to be 0.4 SD (corresponding to a medium effect size) on the primary outcome, with a mean change in the cognitive composite score of 0.5 SD. Assuming a 10% drop-out rate, we will recruit up to N=58 in order to achieve complete datasets for N=52 participants.

Data will be analysed using mixed models using intention-to-treat (ITT) analyses.

Functional MRI-data will be pre-processed and analysed with the FMRIB Expert Analysis Tool (FEAT) and the "randomize" algorithm implemented in FMRIB Software Library (FSL). Functional MRI data will be analysed using a Region of interest (ROI) analysis to assess differences between the ABCR and control group in neural activity in the dlPFC and the hippocampi after 2 weeks. Exploratory whole-brain analyses will be conducted to investigate any effects in other brain regions. Any differences in neural activity will be correlated with potential changes in the cognitive composite score at weeks 2 and post-treatment. If there is a significant correlation with cognition at post-treatment, multiple regression analysis will be carried out, adjusting for mood and demographic characteristics, to assess whether early change in neural activity is predictive of pro-cognitive effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Action-Based Cognitive Remediation on Cognition and Frontal Lobe Activity in Patients With Bipolar Disorder in Remission (PRETEC-ABC)
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : January 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Action Based Cognitive Remediation Behavioral: Action-Based Cognitive Remediation
Active Comparator: Unstructured support group Behavioral: Unstructured support group



Primary Outcome Measures :
  1. Cognitive composite score [ Time Frame: Change from baseline and week 11 ]
    A cognitive composite based on an average of the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter "D", WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB).


Secondary Outcome Measures :
  1. One Touch Stockings of Cambridge [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    A computerized neuropsychological test assessing executive functions

  2. Functional Assessment Short Test [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    A semi-structured interview assessing level of functioning


Other Outcome Measures:
  1. Rey Auditory Verbal Learning Test [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing verbal memory

  2. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing attention

  3. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Digit Span [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing executive functions

  4. Verbal fluency with the letter "D" and 'S" [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing executive functions

  5. WAIS-III Letter-Number Sequencing [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing executive functions

  6. Trail Making Test B [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing psychomotor speed

  7. Trail Making Test A [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing executive functions

  8. Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB) [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing sustained attention

  9. Spatial Working Memory (SWM) from Cambridge Cognition [ Time Frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up ]
    Neuropsychological test assessing sustained attention

  10. Brief University of California, San Diego Performance-Based Skills Assessment-B (UPSA-B) [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    Objective assessment of level of functioning

  11. Sheehan Disability Scale [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    Questionnaire on level of functioning

  12. The Assessment of Quality of Life [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    Questionnaire on quality of life

  13. World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    Questionnaire on quality of life

  14. Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) [ Time Frame: Baseline, two weeks of treatment, week 11,and 6-months follow-up ]
    Questionnaire on subjective cognitive complaints

  15. Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline, week 11, and 6-months follow-up ]
    Questionnaire on occupational functioning



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fluent Danish skills and objective cognitive impairment (a total score below cutoff, or scores below cutoff on a minimum of two out of the five subtests (Verbal Learning Test - Immediate, Working Memory Test, Verbal Fluency Test, Verbal Learning Test - Delayed and Processing Speed Test) on the Screen for Cognitive Impairment in Psychiatry - Danish version (SCIP-D).
  • Patients must meet the ICD-10 diagnosis of BD (type I and II) confirmed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview.

Exclusion Criteria:

  • Daily use of benzodiazepines > 22.5 mg oxazepam, pregnancy, current drug or substance abuse (three months prior to inclusion), previous serious head trauma, severe physical illness, neurological illness, schizophrenia or schizoaffective disorder, dyslexia, claustrophobia, having a pacemaker or other metal implants inside the body and electroconvulsive therapy in the three months prior to inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295305


Locations
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Denmark
Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Lundbeck Foundation
Investigators
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Principal Investigator: Kamilla W Miskowiak, Dr Mental Health Services, Capital Region of Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kamilla Woznica Miskowiak, Professor, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03295305    
Other Study ID Numbers: H-16043480
2012-58-0004 ( Registry Identifier: Danish Data Protection Agency )
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kamilla Woznica Miskowiak, Mental Health Services in the Capital Region, Denmark:
Biomarker
Bipolar Disorder
Cognition
Cognitive Impairment
cognitive remediation
functional magnetic resonance imaging
pro-cognitive effect
Additional relevant MeSH terms:
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Disease
Cognitive Dysfunction
Bipolar Disorder
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Bipolar and Related Disorders