Brain Imaging, Genetics and Treatment for Major Depression

NCT01568684 | Withdrawn Phase 1

• 2 other identifiers: 12009912-M-0099
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Antidepressants help many people with depression, however, some do not seem to benefit as much. Currently, it is not possible to determine who will improve with certain antidepressants. Studies have shown that genes may influence whether an antidepressant works for an individual. Other studies have shown that depressed people tend to have lower levels of a chemical called glutamate in parts of their brain, and that glutamate levels increase after recovering from depression. Researchers want to study the antidepressant citalopram (Celexa) to see how it affects glutamate levels in the brain. They also want to study how a person s genes affect their response to this treatment. Objectives: \- To see whether glutamate levels and certain genes affect how a person responds to a particular antidepressant medication. Eligibility: \- Individuals between 25 and 55 years of age who have been diagnosed with major depression (without psychotic features). Participants may not have tried more than three antidepressant treatments. Design:

• Participants will be screened with a physical exam and medical history. They will answer questions about mood and current feelings of depression, as well as family history of depression. Blood and urine samples will be collected.
• This study will have two phases. The first phase may last up to 7 weeks depending on current antidepressant use and involves one to seven outpatient visits. The second phase lasts 8 weeks and involves five outpatient visits, one every 2 weeks.
• In the first phase, participants will stop taking their current antidepressant medications for at least 2 weeks before the next phase of the study. Participants who are on fluoxetine (Prozac) will need to be off it for 6 weeks.
• At the end of this phase, participants will have brain imaging studies to look at brain function and chemistry.
• In the second phase, participants will take citalopram at the standard dose. They will answer questions about mood and response to the medication. They will also provide blood and saliva samples for tests.
• At the end of this phase, participants will have brain imaging studies to look at brain function and chemistry.

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Keywords

Magnetic Resonance Spectroscopy; Depression; Depression Treatment; Major Depression; Unipolar Depression

Outcome Measures

Primary Outcomes (1)

• Changes in prefrontal glutamate concentration after citalopram treatment.

Secondary Outcomes (2)

• Changes in depressive symptoms after citalopram treatment.

• Association between glutamate changes and genetic variation.

Interventions

Citalopram OTHER

Treatment

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged between 25 and 55 years
• Score of 18 or higher on the 17-item Hamilton Depression Rating Scale (HDRS17). We have set the HDRS17 cutoff score to greater than or equal to18 to increase the contrast signals between remitters and non-remitters, MRS imaging and genotypic groups.
• Meets DSM-IV criteria for chronic or recurrent non-psychotic MDD
• No more than 3 failed FDA-approved antidepressant treatments within the current episode
• No alcohol use in the last 7 days
• Fluent in English or Spanish
• Capacity to understand the nature of the study and provide informed consent

You may not qualify if:

• Lifetime history of schizophrenia, schizoaffective disorder or psychosis not otherwise specified
• Lifetime history of bipolar disorder (I, II, or not otherwise specified)
• Lifetime history of anorexia nervosa or bulimia nervosa
• Current primary obsessive-compulsive disorder (OCD)
• History of intolerability to citalopram
• Lack of response to an adequate trial of citalopram or escitalopram in the current or previous episodes of MDD
• Have failed to respond to more than three antidepressants during current major depressive episode
• Lack of response to 7 or more sessions of ECT in the current or previous episodes of MDD
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
• Females who are sexually active and who are not willing to use effective contraception for 8-weeks while participating in this study or are pregnant or breast feeding
• Concomitant medication use which contraindicates the use of the study medication
• Patients on thyroid medication for hypothyroidism: stable on thyroid medication for \< 2 months
• Current participation in any modality of psychotherapy and the patient is not willing to forgo it during participation
• Have a history of drug or alcohol dependence or current abuse within the last 3 months
• Past history of significant head injury with loss of consciousness for about 24 hours or more

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Related Publications (3)

• Caetano SC, Fonseca M, Olvera RL, Nicoletti M, Hatch JP, Stanley JA, Hunter K, Lafer B, Pliszka SR, Soares JC. Proton spectroscopy study of the left dorsolateral prefrontal cortex in pediatric depressed patients. Neurosci Lett. 2005 Aug 26;384(3):321-6. doi: 10.1016/j.neulet.2005.04.099.

  PMID: 15936878 BACKGROUND

• Cho MK. Understanding incidental findings in the context of genetics and genomics. J Law Med Ethics. 2008 Summer;36(2):280-5, 212. doi: 10.1111/j.1748-720X.2008.00270.x.

  PMID: 18547195 BACKGROUND

• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

  PMID: 13638508 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gonzalo Laje, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 2, 2012
• Study Start: March 12, 2012
• Primary Completion: December 11, 2012
• Study Completion: December 11, 2012
• Last Updated: December 17, 2019

Record last verified: 2012-12-11