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D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

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ClinicalTrials.gov Identifier: NCT01981759
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : July 9, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to testing efficacy, this trial will characterize DCS effects in terms of time course and persistence of response and will examine DCS effects on memory consolidation and cognitive flexibility as possible mediators of DCS enhancement of CBT for delusions.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Delusional Disorder Drug: D-Cycloserine Other: Placebo Behavioral: Cognitive Behavioral Therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Actual Study Start Date : February 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Other: Placebo
Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.
Other Name: Sugar pill

Behavioral: Cognitive Behavioral Therapy
Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Other Name: CBT

Experimental: D-Cycloserine
Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).
Drug: D-Cycloserine
Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.
Other Name: Seromycin

Behavioral: Cognitive Behavioral Therapy
Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Other Name: CBT




Primary Outcome Measures :
  1. Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) [ Time Frame: Baseline to Week 12 ]
    The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.


Secondary Outcome Measures :
  1. Change in Logical Memory Test-WMS-III [ Time Frame: Screening Visit 2 to Baseline ]

    The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories—one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after delays of 30 minutes and 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall.

    We hypothesize that improved memory consolidation tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D.

    The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant.


  2. Change in Alternate Beliefs Exercise (ABE) [ Time Frame: Week 3 to Week 4 ]

    The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported.

    This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration.




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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-68
  • Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder
  • Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic naive for lifetime
  • Willing to participate in CBT
  • Sufficient proficiency in English to complete assessments
  • Score of at least 3 on the SAPS at two assessments, four weeks apart

Exclusion Criteria:

  • Current treatment with clozapine
  • SSRI treatment
  • Active alcohol or other substance abuse within six weeks
  • Unstable medical illness
  • Pregnant or nursing
  • Anemia
  • Renal insufficiency

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): NCT01981759


Locations
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United States, Maryland
Sheppard Pratt
Baltimore, Maryland, United States, 21204
United States, New York
New York Langone Medical Center/Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Donald C Goff, MD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01981759     History of Changes
Other Study ID Numbers: 12-02991
First Posted: November 13, 2013    Key Record Dates
Results First Posted: July 9, 2018
Last Update Posted: April 11, 2019
Last Verified: March 2019

Keywords provided by NYU Langone Health:
Schizophrenia
Delusions
D-Cycloserine
CBT

Additional relevant MeSH terms:
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Cycloserine
Antibiotics, Antitubercular
Anti-Bacterial Agents
Disease
Schizophrenia
Psychotic Disorders
Delusions
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action