D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

NCT01981759 | Completed Phase 4 Results DMC

• 1 other identifier: 12-02991
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Delusional Disorder

Keywords

Schizophrenia; Delusions; D-Cycloserine; CBT

Outcome Measures

Primary Outcomes (1)

• Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)

  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.

  Baseline to Week 12

Secondary Outcomes (2)

• Change in Logical Memory Test-WMS-III

  7 days after Baseline, and 7 days after Screening visit 2

• Change in Alternate Beliefs Exercise (ABE)

  Week 3 to Week 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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; Behavioral: Cognitive Behavioral Therapy

D-Cycloserine

EXPERIMENTAL

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; Behavioral: Cognitive Behavioral Therapy

Interventions

D-Cycloserine DRUG

Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.

Also known as: Seromycin

D-Cycloserine

Placebo OTHER

Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.

Also known as: Sugar pill

Placebo

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

D-Cycloserine; Placebo

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Sheppard Pratt

Baltimore, Maryland, 21204, United States

Location

New York Langone Medical Center/Bellevue Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid; Delusions

Interventions

Cycloserine; Sugars; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Principal Investigator
• Organization: NYU Langone Health

donald.goff@nyumc.org

646-754-4843

Study Officials

• Donald C Goff, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 13, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 25, 2020
• Results First Posted: July 9, 2018

Record last verified: 2020-03

Locations

US (2)