NCT00455702

Brief Summary

The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

April 2, 2007

Results QC Date

June 11, 2014

Last Update Submit

July 14, 2014

Conditions

Schizophrenia

Keywords

schizophreniacognitiond-cycloserinememory

Outcome Measures

Primary Outcomes (1)

  • Main Outcome Measure: The Change From Baseline to Week 8 on the SANS

    The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).

    Baseline score vs. Week 8

Secondary Outcomes (1)

  • Treatment Effects on the Positive Syndrome Subscale of the PANSS

    Baseline score vs. Week 8 score

Study Arms (2)

D-cycloserine

EXPERIMENTAL

50 mg d-cycloserine

Drug: d-cycloserine

Placebo

PLACEBO COMPARATOR

50 mg placebo

Drug: d-cycloserine

Interventions

d-cycloserineDRUG

50mg dose d-cycloserine v placebo

D-cycloserinePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age 18-65 years
  • Diagnosis of schizophrenia or schizoaffective disorder, depressed type
  • Stable dose of antipsychotic for at least 4 weeks.
  • Able to provide informed consent
  • Able to complete a cognitive battery

You may not qualify if:

  • Current treatment with clozapine
  • Dementia
  • Seizure disorder
  • Unstable medical illness
  • Active substance abuse
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Goff DC, Cather C, Gottlieb JD, Evins AE, Walsh J, Raeke L, Otto MW, Schoenfeld D, Green MF. Once-weekly D-cycloserine effects on negative symptoms and cognition in schizophrenia: an exploratory study. Schizophr Res. 2008 Dec;106(2-3):320-7. doi: 10.1016/j.schres.2008.08.012. Epub 2008 Sep 16.

    PMID: 18799288RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Limitations and Caveats

As the first study of once-weekly dosing in Schizophrenia, this study was exploratory and so results must be considered preliminary. Additional studies are needed to replicate these findings.

Results Point of Contact

Title
Donald C Goff
Organization
Massachusetts General Hopsital
goff@psych.mgh.harvard.edu
617-912-7899

Study Officials

  • Donald C Goff, M.D.

    Massachusetts General Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Director of the Schizophrenia Clinical and Research Program

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

July 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 7, 2014

Results First Posted

August 7, 2014

Record last verified: 2014-07

Locations

US(1)