Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01557946
First received: March 9, 2012
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

Primarily, this study seeks to evaluate whether citalopram treatment is associated with an increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC) from baseline to day 3 of treatment. Additionally, this study would like to examine whether citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from baseline to day 7 of treatment.


Condition Intervention Phase
MDD
Citalopram
Major Depressive Disorder
Drug: citalopram
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Gln/Glu ratio in the rostral anterior cingulate cortex (rACC) from baseline to day 3 of treatment. [ Time Frame: Participants will undergo MR scan on Day 3 of Treatment ] [ Designated as safety issue: No ]
    Citalopram treatment is associated with an increase in the Gln/Glu ratio in the rostral anterior cingulate cortex (rACC) from baseline to day 3 of treatment.


Secondary Outcome Measures:
  • Gln/Glu ratio in the rACC from baseline to day 7 of treatment [ Time Frame: Participants will undergo MR scan on Day 7 of treatment ] [ Designated as safety issue: No ]
    Citalopram treatment is associated with an increase in the Gln/Glu ratio in the rACC from baseline to day 7 of treatment.


Estimated Enrollment: 25
Study Start Date: March 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citalopram 20 mg Drug: citalopram
Citalopram tablet taken once daily. Dosage depends on study arm.
Active Comparator: Citalopram 40 mg Drug: citalopram
Citalopram tablet taken once daily. Dosage depends on study arm.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age ≥ 18 and ≤ 65
  2. Meets DSM-IV criteria for MDD
  3. Current score of ≥ 18 on the 21-item Hamilton Depression Rating Scale (HAM-D).

Exclusion Criteria:

  1. Unwillingness or inability to provide written informed consent.
  2. Current suicidal ideation
  3. Active psychotic symptoms
  4. Lifetime history of bipolar disorder, schizophrenia, or OCD
  5. Failed treatment with an adequate trial of ≥ 2 antidepressants during the current major depressive episode ("failure" will be defined as ≤ 50% subjective improvement, and an "adequate trial" will be defined as at least 4 weeks of treatment using at least the minimum dose of the antidepressant recommended by the manufacturer in product labeling)
  6. DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
  7. Any history of treatment with electroconvulsive therapy
  8. Positive urine toxicology screen for any drug of abuse or excluded medication at screening. Opiate pain medication being taken for a medical condition is exempt from needing a negative opiate screen.
  9. Clinically significant medical or neurologic disease, as judged by the principal investigator, which would increase the risk to the participant or interfere with interpretation of results
  10. Female participants with a positive urine pregnancy test at screening

12. Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization).

13. Any screening laboratory abnormality deemed clinically significant by the investigator 14. A QTc interval on screening ECG of ≥ 450 msec. 15. Use of any excluded medications (see Section 6.7 below) that cannot be discontinued during the screening phase 16. Previous failure to respond to treatment with citalopram that would, in the judgment of the investigator, constitute an adequate trial in MDD 17. Treatment with any investigational medications within 30 days prior to screening 18. Any contraindications to having an MRI scan, including cardiac pacemakers, metal vascular clips or stents, artificial heart valves, certain kinds of prostheses, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others), transdermal drug delivery systems, and certain tattoos with metallic ink 19. Left-handedness

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557946

Contacts
Contact: Erin Ryan, B.A. 617-855-2984

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Erin Ryan, B.A.    617-855-2984      
Principal Investigator: Brian P. Brennan, M.D.         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Brian P. Brennan, M.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: Brian P. Brennan, MD, Associate Director of Translational Neuroscience Research, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01557946     History of Changes
Other Study ID Numbers: 2011-P-001192
Study First Received: March 9, 2012
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014