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p11 Protein Levels in Patients With Major Depressive Disorder Treated With Citalopram

NCT00697268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2019-12-17

No results posted yet for this study

Summary

This study will compare levels of p11 protein in people with and without major depressive disorder (MDD) and examine if p11 levels in patients are affected by treatment with citalopram (Celexa).

Healthy normal volunteers and patients with chronic or recurrent major depression between 18 and 65 years of age may be eligible for this study.

Participants undergo the following tests and procedures:

Healthy Volunteers

* Psychiatric interview and medical examination, questions about family history
* Blood draw

Patients with MDD

Phase 1 - Evaluation and Discontinuation of Medications

* Physical examination, electrocardiogram, blood tests
* Gradual antidepressant medication withdrawal, followed by 2- to 6-week drug-free period. If needed, medicines for anxiety and difficulty sleeping may be prescribed.

Phase 2 Citalopram Treatment

* Start daily citalopram treatment
* Evaluations at the start of phase 2 and every week for 8 weeks with following procedures:
* Symptoms ratings interview and questionnaires
* Review of side effects and new medications
* Blood pressure and pulse measurements
* Blood and urine tests

At the end of the study, plans are developed for long-term treatment and transfer of care to the patient s own physician.

...

Conditions

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Carlos A Zarate, M.D. · National Institute of Mental Health (NIMH)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-03
Completion
2016-07-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697268 on ClinicalTrials.gov