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Bipolar DisorderPhase 3DCSNCT01934972

A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder

A Phase 3 study testing CR + DCS (D-cycloserine) in people with Bipolar Disorder, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Individuals with bipolar suffer from problems in basic cognitive skills such as memory and concentration. Unfortunately, there are no current treatments that have been shown to improve cognitive skills among individuals with bipolar disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
CR + DCS (D-cycloserine)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2013to Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • [i] Hypersensitivity to previous receipt of cycloserine per subject report [ii] Epilespy or history of seizures as assessed using the Medical History form [iii] Meets DSM-IV criteria for alcohol or drug abuse in the past month or dependence in the past three months.
  • [iv] Active suicidal or homicidal ideation [v] Initiation or increase in dosage of any antidepressant within six weeks, or mood stabilizer within four weeks as assessed using the Medication Checklist.
  • [vi] Previous or current participation in cognitive remediation per subject report [vii] Currently taking d-cycloserine [viii] Reduced kidney or liver functioning, vitamin B12 deficiency, folic acid deficiency, megaloblastic anemia, or sideroblastic anemia per baseline safety labs.
  • [ix] Currently taking medication known to have problematic interactions with d-cycloserine, including etionamide and isoniazid.
  • [x] History of the blood disease porphyria as assessed using the Medical History form [xi] Current active symptoms of psychosis defined as not meeting existing guidelines [12] for remission of psychotic symptoms using the Positive and Negative Syndrome Scale.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Medical Center South Campus

    Tucson, Arizona, 85713

Other trials in United States

About this study

Individuals with bipolar suffer from problems in basic cognitive skills such as memory and concentration. Unfortunately, there are no current treatments that have been shown to improve cognitive skills among individuals with bipolar disorder.

Computerized cognitive remediation (CR) is a treatment that has been shown to improve cognitive skills among individuals with serious mental illnesses other than bipolar disorder, such as schizophrenia. This treatment involves completing a series of activities on a computer that have been shown to improve cognitive skills.

Read more

D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis. Recent studies have suggested that this drug may also improve individuals' ability to learn. Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the benefit that individuals receive from participation in cognitive remediation.

To test this hypothesis, approximately forty subjects will be randomized to one of two study arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the benefit that individuals with bipolar disorder receive from participation in cognitive remediation.

Read the detailed description

Individuals with bipolar disorder suffer from a broad array of cognitive deficits that may hinder their ability to achieve successful community functioning. Consequently, greater attention has recently been directed toward the development of strategies to ameliorate these cognitive deficits. One strategy which has been shown to be successful in this endeavor is cognitive remediation (CR). This intervention, which is recognized as a "best practice" in the treatment of serious mental illness, is typically comprised of a series of repeated exercises delivered by a clinician or via a computer that are designed to improve performance in cognitive functioning. Yet, despite the promise of cognitive remediation, the benefit of this intervention among individuals with bipolar disorder has yet to be investigated.

Recently, studies have demonstrated that d-cycloserine (DCS), an N-methyl-D-aspartate receptor (NMDAR) agonist, may facilitate the learning process for emotional and non-emotional information in both humans and animals. These results raise the possibility that DCS may increase the benefits associated with the receipt of cognitive remediation among individuals with bipolar disorder. To date, we are unaware of any study which has examined whether concurrent receipt of DCS may increase the benefits produced by cognitive remediation among individuals with a severe mental illness.

Thus, we propose to complete an exploratory investigation of augmenting cognitive remediation with DCS among individuals with bipolar disorder. Approximately forty subjects will be randomized to one of two study arms: [i] CR + DCS; or [ii] CR + placebo. The primary outcome of interest will be changes in cognitive functioning before and after receipt of the cognitive remediation intervention. Secondary outcomes of interest will be changes in symptomatology, social and vocational functioning, and performance of tasks of everyday living.

Being tested
CR + DCS (D-cycloserine), CR + placebo
Keywords
Bipolar disorder
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CR + DCS (D-cycloserine)Other

    Also called DCS and Cognitive Remediation

    CR + DCS

  • CR + placeboOther

    Also called Cognitive Remediation

    CR + placebo

Study groups in NCT01934972
Study groupRoleWhat they receive
CR + DCSExperimentalSubjects will receive Cognitive Remediation and active study drug.
Receives: Other: CR + DCS (D-cycloserine)
CR + placeboActive comparatorCognitive Remediation and placebo
Receives: Other: CR + placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Cognitive Functioning

    Level of cognitive functioning will be assessed via overall cognitive composite score from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery. Scores on the MATRICS are presented at T-scores with a mean of 50 and standard deviation of 10 as compared to a normative sample. The possible range of scores are 0-100. Higher scores are indicative of better cognitive functioning.

    Change from baseline in cognitive functioning was calculated by taking the MATRICS overall cognitive functioning score at 26-week follow-up and subtracting the MATRICS overall cognitive composite score from baseline. Positive values on this score are indicative of improvements in cognitive functioning from baseline.

    Missing values on the MATRICS were addressed using multiple imputation

    Measured: 26 weeks

Secondary outcomes (4)

  1. Change From Baseline in Manic Symptomatology

    Manic symptomatology assesed using the Yung Mania Scale. Total scores on this scale range from 0 to 60 with higher scores indicative of greater severity of manic symptoms. Change scores from baseline were calculated by subtracting baseline total scores on this measure from 26-week scores. For this change score, positive values indicate that manic symptom severity was worse at 26-week follow-up than at baseline

    Measured: 26 weeks

  2. Change From Baseline in Depressive Symptomatology

    Depressive symptomatology assessed using the Inventory of Depressive Symptomatology (Clinician-Rated). Total scores on this measure range from 0-84 with higher scores indicative of worse depressive symptomatology. Change from baseline in depressive symptomatology was calculated by subtracting baseline scores on the Inventory of Depressive Symptomatology from 26-week scores on this measure. Positive values of this change score indicate that depressive symptoms were worse at 26-week assessment than at baseline assessment.

    Measured: 26 Weeks

  3. Change From Baseline in Social Functioning

    Social functioning assessed using the Social Functioning Scale. Total score calculated by converting all subscale scores to a standard score with mean = 100 and standard deviation = 15. These subscale scores are then averaged to calculate the total score. There is no set minimum or maximum on this scale given this scoring procedure.

    Change from baseline in social functioning was calculated by subtracting total scores at baseline assessment from total scores at 26-week. A positive value on this change score are indicative of better social functioning at 26-week assessment than at baseline.

    Measured: 26 Weeks

  4. Change From Baseline in Functional Capacity

    Functional capacity assessed using the Brief University of California, San Diego Performance-Based Skills Assessment (UPSA). Scores range from 0-100 with higher scores indicative of greater functional capacity.

    Change score were calculated by subtracting baseline scores on the UPSA from scores from the 6-month assessment. Positive values are indicative of higher functional capacity at 26-week follow-up as compared to baseline assessment.

    Measured: 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01934972
Sponsor's protocol ID
12-0926-01 Breitborde DCS
Acronym
DCS
Status last verified
Jun 2020
First submitted
19 Aug 2013
Last updated
16 Jun 2020
Data monitoring committee
Yes

Publications

  • Breitborde NJ, Dawson SC, Woolverton C, Dawley D, Bell EK, Norman K, Polsinelli A, Bernstein B, Mirsky P, Pletkova C, Grucci F 3rd, Montoya C, Nanadiego B, Sarabi E, DePalma M, Moreno F. A randomized controlled trial of cognitive remediation and d-cycloserine for individuals with bipolar disorder. BMC Psychol. 2014 Oct 10;2(1):41. doi: 10.1186/s40359-014-0041-4. eCollection 2014.

    PubMed 25566387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CR + DCS (D-cycloserine) in people with Bipolar Disorder, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cognitive Functioning (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01934972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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