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SchizophreniaPhase 4NCT00742079

Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia

A Phase 4 study testing D-cycloserine and Cognitive Behavioral Therapy in people with Schizophrenia, run by Massachusetts General Hospital 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

This study will examine whether pretreatment with D-cycloserine before cognitive behavioral therapy can reduce impairments still present in people with stable cases of schizophrenia as well as determine which traits make schizophrenics most likely to respond to D-cycloserine treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
D-cycloserine and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Sep 2006to Dec 2010
Phase
Phase 4
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

  • Meets DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophrenia, paranoid subtype, based on chart review, Structured Clinical Interview for DSM-IV, and consultation with the patient's clinicians
  • Medicated with an antipsychotic agent other than clozapine at a stable dose for at least 6 weeks
  • Scores at least 3, or "moderate," on the Scale for the Assessment of Positive Symptoms global delusion rating
  • Paranoid or referential delusional content
  • Never engaged in formal CBT psychotherapy in the past

Who cannot join

  • Diagnosis of a comorbid Axis I disorder other than schizophrenia
  • Active substance abuse or dependence within 6 months
  • Significant suicidal ideation within 6 weeks
  • Pregnant or nursing
  • Unstable medical disorder
  • impaired renal clearance (creatinine <60mg/dL/min)
  • Suffering from dementia
  • Suffering from seizure disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MGH Schizophrenia Program - Freedom Trail Clinic

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pilot Study of Pretreatment D-cycloserine for CBT-assessment of Paranoid Delusions in Schizophrenia

This study will examine whether pretreatment with D-cycloserine before cognitive behavioral therapy can reduce impairments still present in people with stable cases of schizophrenia as well as determine which traits make schizophrenics most likely to respond to D-cycloserine treatment.

Read the detailed description

Schizophrenia is a debilitating chronic condition that affects approximately 1 % of Americans, who experience symptoms such as hallucinations, delusions, and disorders of thought and movement. These symptoms are described as positive symptoms, because they are experienced in addition to what healthy individuals experience. Negative symptoms, which are reductions in normal functioning, and cognitive deficits, which are problems in thinking, also plague people with schizophrenia. The negative symptoms and cognitive deficits associated with schizophrenia are produced in otherwise healthy people by neurotransmitters inhibiting the glutamatergic N-methyl-d-aspartate NMDA receptors in the brain. This inhibition of NMDA receptors also causes intensification of psychotic symptoms in otherwise stabilized schizophrenic patients. The drug D-cycloserine partially excites NMDA receptors, and it has been used to help patients with anxiety disorders to overcome phobias while they are receiving cognitive behavioral therapy. This study will examine whether D-cycloserine can increase the cognitive flexibility of someone undergoing CBT and thereby enhance the therapy's ability to reduce a patient's belief in paranoid delusions, preoccupation with delusions, and related distress.

All participants will be screened to ensure proper diagnosis of schizophrenia without other conditions. Those who pass will be randomly assigned to receive either D-cycloserine first or a placebo pill first. One week after the screening, participants in the D-cycloserine group will be given the drug before a 1-hour session of simulated CBT treatment. Those in the placebo condition will receive a placebo pill before an identical session. Two weeks after the screening, both groups will be called back for another session of CBT, but the pills they receive will be switched. Those who received D-cycloserine the first week will receive placebo, and those who received placebo will receive D-cycloserine. The CBT sessions will attempt to increase cognitive flexibility in patients by asking them to provide alternate explanations for common situations. At screening, at the start of visits on the first and second weeks, and at a follow-up visit on the third week, participants will undergo a series of assessments, including interviews, computerized tests, and self-report measures. Belief in, preoccupation with, and distress caused by delusions, as well as degree of cognitive flexibility, will be assessed.

Conditions
Schizophrenia
Being tested
D-cycloserine, Cognitive Behavioral Therapy
Keywords
Paranoid Schizophrenia, Paranoid Delusions, CBT, D-Cycloserine
Medical subject headings
Schizophrenia, Schizophrenia, Paranoid

What participants receive

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

  • D-cycloserineDrug

    Also called Seromycin

    Single, fixed 50-mg dose of D-cycloserine administered 1 hour prior to a CBT session

  • Cognitive Behavioral TherapyBehavioural

    Also called CBT

    One-hour talk therapy session with a trained clinician aimed at increasing cognitive flexibility by examining alternative explanations to everyday situations

Study groups in NCT00742079
Study groupRoleWhat they receive
1 D-cycloserine, placeboExperimentalParticipants will receive D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive placebo 1 hour before a CBT session on Week 2.
Receives: Drug: D-cycloserine; Behavioral: Cognitive Behavioral Therapy
2 Placebo, D-cycloserineExperimentalParticipants will receive placebo 1 hour before a CBT session on Week 1, and they will receive D-cycloserine 1 hour before a CBT session on Week 2.
Receives: Drug: D-cycloserine; Behavioral: Cognitive Behavioral Therapy

What is being measured

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

  1. Change in Alternative Beliefs Assessment

    Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.

    Measured: Baseline to Week 2

Secondary outcomes (4)

  1. Change in Psychotic Rating Scales (PSYRATS) Delusion Score

    The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes

    Measured: Baseline to Week 2

  2. Change in Beck Cognitive Insight Scale (BCIS)

    The BCIS is a 15-item self-report scale with Likert items 0-3. It consists of a composite score, where higher scores represent better outcomes, and there are 2 subscales: 1) Self-Reflectiveness (higher scores represent better outcomes) and 2) Self-Certainty (higher scores represent worse outcomes). The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty.

    Step 1. Score every item on the BCIS from "0" to "3" according to the following rule:

    "Do Not Agree at All" = 0, "Agree Slightly" = 1, "Agree a Lot" = 2, "Agree Completely" = 3 Step 2. Calculate self-reflectiveness subscale: sum items 1, 3, 4, 5, 6, 8, 12, 14, and 15.

    Step 3. Calculate self-certainty subscale: sum items 2, 7, 9, 10, 11, and 13. Step 4. Calculate BCIS composite index: self-reflectiveness minus self-certainty.

    Measured: Baseline to Week 2

  3. Change in Bead Task Score Measuring Probabilistic Reasoning

    The Bead task is a reasoning task, where the number of beads guessed is the numeric value represented in the data. The lower end range is 1, and there is no upper range limit. Higher scores represent better outcomes.

    Measured: Baseline to Week 2

  4. Change in the Maudsley Assessment of Delusions Scale

    This scale is a one-question item added on to the Bead Task. The one item asks for a certainty rating, from 1-3. Higher scores represent better outcomes.

    Measured: Baseline to Week 2

Timeline

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

  1. First posted27 Aug 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionJul 2010
  4. Study completionDec 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00742079
Sponsor's protocol ID
P50MH060450
Other IDs
2P50MH060450-07A1, DATR A3-NSC
Status last verified
Sep 2014
First submitted
25 Aug 2008
Last updated
19 Dec 2017
Data monitoring committee
No

Publications

  • Gottlieb JD, Cather C, Shanahan M, Creedon T, Macklin EA, Goff DC. D-cycloserine facilitation of cognitive behavioral therapy for delusions in schizophrenia. Schizophr Res. 2011 Sep;131(1-3):69-74. doi: 10.1016/j.schres.2011.05.029. Epub 2011 Jun 30.

    PubMed 21723096

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing D-cycloserine and Cognitive Behavioral Therapy in people with Schizophrenia, run by Massachusetts General Hospital 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 5 inclusion and 8 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 19 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Sep 2014). 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 in Alternative Beliefs Assessment (time frame: Baseline to Week 2). 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 NCT00742079, 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 19 Dec 2017.

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