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Trial record 83 of 588 for:    ESCITALOPRAM AND Celexa

Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression

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ClinicalTrials.gov Identifier: NCT01557946
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 20, 2012
Results First Submitted Date  ICMJE January 20, 2017
Results First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 12, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Mean Difference From Baseline to Day 3 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group [ Time Frame: Change from Baseline to Day 3 ]
Estimated mean difference (day 3 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 3 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
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 ]
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.
Change History Complete list of historical versions of study NCT01557946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Mean Difference From Baseline to Day 7 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group [ Time Frame: Change from baseline to day 7 ]
Estimated mean difference (day 7 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 7 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
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 ]
Citalopram treatment is associated with an increase in the Gln/Glu ratio in the rACC from baseline to day 7 of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression
Official Title  ICMJE Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression
Brief Summary 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. In order to more fully examine baseline neurochemical and functional abnormalities in participants with MDD, we also seek to scan a group of age- and sex-matched non-depressed comparison individuals in order to perform between-group analyses of baseline neuroimaging measures.
Detailed Description Little is known about the acute effects of standard antidepressant treatments on brain glutamate and gamma-amino-butyric acid (GABA) levels, and their association with clinical response. In the current study, we used proton magnetic resonance spectroscopy (1H-MRS) to examine longitudinally the effects of citalopram on the glutamine/glutamate ratio and GABA levels in the pregenual anterior cingulate cortex (pgACC) - a region that has been repeatedly implicated in antidepressant response - of individuals with major depressive disorder (MDD). We acquired 1H-MRS scans at baseline and at days 3, 7, and 42 of citalopram treatment in nineteen unmedicated individuals with MDD. Ten age- and sex-matched non-depressed comparison individuals were scanned once and did not receive citalopram. The association between baseline metabolites and the change in metabolites from baseline to each time point and change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 42 was assessed by longitudinal regression analysis, adjusting for age, sex, and baseline MADRS, using generalized estimating equations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label administration of citalopram to participants with major depressive disorder. MRI scans performed at baseline and days 3, 7, and 42. An age- and gender-matched group of healthy volunteers did not receive citalopram and received on MRI scan to perform between-group baseline analyses.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • MDD
  • Citalopram
  • Major Depressive Disorder
Intervention  ICMJE Drug: citalopram
citalopram 20-40 mg daily
Other Name: Celexa
Study Arms  ICMJE
  • Experimental: Major Depression
    Participants with major depressive disorder received citalopram 20-40 mg daily for 6 weeks. MRI scans were acquired at baseline and days 3, 7, and 42.
    Intervention: Drug: citalopram
  • No Intervention: Healthy Volunteers
    Healthy volunteer participants did not receive citalopram and performed one MRI scan.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2012)
25
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01557946
Other Study ID Numbers  ICMJE 2011-P-001192
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian P. Brennan, MD, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian P. Brennan, M.D. Mclean Hospital
PRS Account Mclean Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP