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DepressionNCT00697268

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

An observational study of Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depression
How many people
38 participants
Where
1 siteUnited States
Study dates
3 Jun 2008to 28 Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS:
  • age 18-65 years
  • written informed consent completed (consent-incapacitated subjects will not be eligible)
  • score 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
  • meets DSM-IV criteria for chronic or recurrent nonpsychotic MDD
  • patients who are on non-excluded concomitant medications.
Show all 24Show fewer
  • no more than 3 failed antidepressant treatments within the current major depressive episode
  • no alcohol use (last 7 days)
  • ADDITIONAL CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
  • age 18 55 years
  • subjects must have either a family history of mood disorders, or have a history of
  • multiple major depressive episodes
  • age of onset of depressive symptoms less than 45 years
  • no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
  • no use of benzodiazepines within 2 weeks of either MRI scan
  • CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS:
  • age 18-65 years
  • written informed consent completed
  • no current or past diagnosis of axis I psychiatric disorder (DSM-IVTR)
  • no alcohol use (last 7 days)
  • physically healthy
  • ADDITIONAL CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS FOR MRI IMAGING:
  • age 18 55 years
  • no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.

Who cannot join

  • CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS:
  • history of bipolar disorder (I, II, or NOS) (lifetime)
  • history of schizophrenia
  • history of schizoaffective disorder or
  • psychosis NOS (lifetime)
  • history of anorexia nervosa or bulimia nervosa (lifetime)
Show all 36Show fewer
  • current primary obsessive-compulsive disorder (OCD) or current post traumatic stress disorder (PTSD) whose onset preceded the onset of Major Depressive Disorder
  • history of clear-cut intolerability to the study medication
  • lack of response to an adequate trial of the study medication (citalopram) in the current or past episodes of MDD
  • did not respond to 7 or more sessions of ECT in the current episode of MDD
  • Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • has general medical condition which contraindicates the use of the study medication
  • is on concomitant medication which contraindicates the use of the study medication
  • requires immediate hospitalization for psychiatric disorder
  • requires antipsychotic medications or mood stabilizers
  • Non-postmenopausal (less than 2 years since last period) females of childbearing potential who are sexually active and who are not using adequate (hormonal, double barrier, surgical) contraception, or who are pregnant or breast feeding
  • patients currently taking any of the exclusionary medications detailed in protocol (including antipsychotic medications, anticonvulsant medications, antidepressant medications, mood stabilizers, central nervous system stimulants) in the 2 weeks prior to Study Period II.
  • patients taking thyroid medication for hypothyroidism may be included if they have been stable on the medication for greater than 3 months
  • patients can participate in a modality of psychotherapy that is not targeting the symptoms of depression (e.g., supportive therapy, marital therapy)
  • therapy that is depression specific, such as Cognitive Therapy (CT) or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation
  • subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.
  • current alcohol dependence or abuse (last 3 months)
  • patient has a prolonged QTc (greater than or equal to 450 msec), as shown on ECG
  • Current NIMH employee/staff or their immediate family member.
  • ADDITIONAL CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
  • subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
  • subjects with structural lesions visible on MRI will be excluded from further MRI procedures
  • subjects with diabetes or hypertension will be excluded
  • CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
  • subjects currently taking any of the exclusionary medications detailed in protocol in the 2 weeks prior to evaluation
  • current alcohol dependence or abuse (last 3 months)
  • history of major depression or bipolar disorder in any first degree relative
  • ADDITIONAL CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
  • subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
  • subjects with structural lesions visible on MRI will be excluded from further MRI procedures
  • subjects with diabetes or hypertension will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read more

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.

...

Read the detailed description

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.

Conditions
Depression
Keywords
Depression, Depression Treatment, Unipolar Depression, Citalopram, Serotonin, Major Depression, Healthy Volunteer, HV
Medical subject headings
Depression, Depressive Disorder, Depressive Disorder, Major

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. We will study whether blood cell levels of p11 differ between healthy individuals and patients with depression. Moreover, we will study whether the levels of p11 are affected by treatment with the selective serotonin reuptake inhibitor, citalopr...

    Measured: Baseline, +1 week, +2 weeks, +3 weeks, +4 weeks, +5 weeks, +6 weeks, +7 weeks, +8 weeks

Secondary outcomes (1)
  1. 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).

    Measured: Baseline, +1 week, +2 weeks, +8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study start3 Jun 2008
  3. Study completion28 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697268
Sponsor's protocol ID
080150
Other IDs
08-M-0150
Status last verified
28 Jul 2016
First submitted
12 Jun 2008
Last updated
17 Dec 2019
Results posted
No

Publications

  • Barnes NM, Sharp T. A review of central 5-HT receptors and their function. Neuropharmacology. 1999 Aug;38(8):1083-152. doi: 10.1016/s0028-3908(99)00010-6.

    PubMed 10462127
  • Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211.

    PubMed 14728109
  • Katon W, Von Korff M, Lin E, Walker E, Simon GE, Bush T, Robinson P, Russo J. Collaborative management to achieve treatment guidelines. Impact on depression in primary care. JAMA. 1995 Apr 5;273(13):1026-31.

    PubMed 7897786

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

We will study whether blood cell levels of p11 differ between healthy individuals and patients with depression. Moreover, we will study whether the levels of p11 are affected by treatment with the selective serotonin reuptake inhibitor, citalopr... (time frame: Baseline, +1 week, +2 weeks, +3 weeks, +4 weeks, +5 weeks, +6 weeks, +7 weeks, +8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00697268, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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