NCT00576095

Brief Summary

The primary objective of this study is to investigate the relationships among findings in structural and functional neuroimaging, cognitive testing and HPA (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

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

August 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

6.8 years

First QC Date

December 14, 2007

Last Update Submit

March 12, 2014

Conditions

DepressionPsychotic DisordersDepressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • Cortisol

    Hourly serum cortisol

    baseline

Secondary Outcomes (1)

  • Cognitive function

    Baseline

Study Arms (3)

PMD

Patients diagnosed with major depression with psychotic features

NPMD

Patients diagnosed with major depression without psychotic features

Controls

Participants with no psychiatric or depression history

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major depression with psychosis Major depression without psychosis Healthy controls

You may qualify if:

  • DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without psychotic features in a major depressive episode.
  • item HAM-D score greater than or equal to 21.
  • Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
  • Between 21 - 85 years of age.
  • If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
  • Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.

You may not qualify if:

  • ECT in the 4 months prior to the study.
  • Abuse of drugs or alcohol in the 6 months prior to study.
  • Unstable or untreated hypertension, or cardiovascular disease.
  • Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  • Any Axis II diagnosis or traits which would make participation in the study difficult.
  • Current pregnancy or lactation.
  • Personal history of Axis I or Axis II disorders.
  • Active unstable medical problems.
  • Abuse of drugs or alcohol in the 6 months prior to study.
  • Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  • Currently pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Cherian K, Schatzberg AF, Keller J. HPA axis in psychotic major depression and schizophrenia spectrum disorders: Cortisol, clinical symptomatology, and cognition. Schizophr Res. 2019 Nov;213:72-79. doi: 10.1016/j.schres.2019.07.003. Epub 2019 Jul 12.

    PMID: 31307859DERIVED

  • Keller J, Gomez R, Williams G, Lembke A, Lazzeroni L, Murphy GM Jr, Schatzberg AF. HPA axis in major depression: cortisol, clinical symptomatology and genetic variation predict cognition. Mol Psychiatry. 2017 Apr;22(4):527-536. doi: 10.1038/mp.2016.120. Epub 2016 Aug 16.

    PMID: 27528460DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

DepressionPsychotic DisordersDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood Disorders

Study Officials

  • Alan Schatzberg

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Jennifer Keller

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

August 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

US(1)