ClinicalTrials.gov
ClinicalTrials.gov Menu

D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01981759
Recruitment Status : Recruiting
First Posted : November 13, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York University School of Medicine

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 Drug: Placebo Behavioral: Cognitive Behavioral Therapy Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).
Drug: Placebo
Participants will receive 12 weekly administrations of 50mg 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 50 mg 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
Drug: Placebo
Participants will receive 12 weekly administrations of 50mg 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



Primary Outcome Measures :
  1. Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) [ Time Frame: Baseline, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 24, Week 36 ]
    The change in the Delusions section of the Psychotic Symptoms Rating Scale (PSYRATS)from Baseline to Week 12.


Secondary Outcome Measures :
  1. Change in Logical Memory Test-WMS-III [ Time Frame: Screening Visit 2, Baseline, Week 3, ]
    The change in the WMS-III from screening visit 2 to baseline, as a predictor of later change in PSYRATS-D scores from baseline to week 12.

  2. Change in Alternate Beliefs Exercise (ABE) [ Time Frame: Week 3, Week 4, Week 12 ]
    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.



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.


Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
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


Contacts
Contact: Erica Diminich, Ph.D. 646-754-4803 Erica.Diminich@nyumc.org
Contact: Amber Lin, BA 646-754-5466 Amber.Lin@nyumc.org

Locations
United States, Maryland
Sheppard Pratt Recruiting
Baltimore, Maryland, United States, 21204
Contact: Faith Dickerson, PhD         
Contact: Emily Katsafanas, BA         
United States, New York
New York Langone Medical Center/Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Donald C Goff, MD    646-754-4843    Donald.Goff@nyumc.org   
Principal Investigator: Donald C Goff, MD         
Sponsors and Collaborators
New York University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Donald C Goff, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01981759     History of Changes
Other Study ID Numbers: 12-02991
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by New York University School of Medicine:
Schizophrenia
Delusions
D-Cycloserine
CBT

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