Depression Clinical Trial
Official title:
An Investigation to Determine Whether Levels of P11 Protein in Peripheral Blood Cells Correlate With Treatment Response to Citalopram in Patients With Major Depressive Disorder
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.
...
Major depressive disorder (MDD) is a serious, debilitating, life-shortening illness that
affects many persons of all ages and backgrounds. While treatments are effective for a
significant portion of patients with MDD, progress in developing more effective treatments is
lagging. Furthermore, with regards to existing antidepressant medications, there are yet no
reliable predictors of the likelihood of remission, response or non-response with an initial
trial of an antidepressant medication. Identifying factors that are likely to predict
response would have the advantage of personalizing treatment to a particular individual; that
is selecting the antidepressant medication that is most likely to give the greatest
probability of having a favorable outcome.
The serotonin system has been implicated in the pathophysiology of depression and mechanism
of action of existing effective antidepressant treatments. Fourteen different serotonin
receptors have been identified to date. One of them, 5-HT1B, plays an important role in
regulating serotonin neurotransmission. Recently, p11 (a member of the S100 family of
proteins) was found to interact with 5-HT1B receptors (Svenningsson et al 2006; Svenningsson
and Greengard 2007). p11 mRNA levels are markedly reduced in the forebrain in helpless
H/Rouen mice and the level of p11 mRNA was down-regulated in the anterior cingulate cortex
from depressed patients. p11 mRNA is distributed in an anatomical pattern that closely
resembled that of 5-HT1B receptor mRNA, including cortex, hippocampus, hypothalamus and raphe
nuclei. Chronic administration of the antidepressants imipramine, tranylcypromine, and
citalopram significantly increase the level of p11 in cortex. Finally, we have found that
chronic treatment with fluoxetine increases p11 in peripheral mononuclear cells in monkeys.
We will now study whether the blood cell levels of p11 differ between healthy individuals and
patients suffering from unipolar depression. Moreover, we will study whether the levels of
p11 are affected by treatment with the selective serotonin reuptake inhibitor, citalopram.
Complementary work will continue at other laboratories to better characterize the role of p11
in the pathophysiology of depression (e.g., animal studies, post-mortem studies).
In addition, we will also acquire a battery of magnetic resonance imaging (MRI) scans in a
subset of 45 more homogeneous depressed subjects, and 45 matched healthy controls at baseline
and at 8 weeks. There is a growing body of evidence implicating morphometric and physiologic
abnormalities, measureable by MRI, in the pathophysiology of major depressive disorder. We
will assess both baseline differences between depressed subjects and healthy controls,
treatment effects, and search for possible MRI markers predicting treatment response.
This is an open label study which will be performed at the National Institute of Mental
Health. In all, 82 adult subjects with major depressive disorder, between the ages of 18 and
65 years, will be recruited from the community. In addition, we will perform p11 measurements
in blood cells from 64 healthy control subjects.
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