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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01557946
Other study ID # 2011-P-001192
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received March 9, 2012
Last updated September 21, 2015
Start date March 2012

Study information

Verified date September 2015
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
citalopram
Citalopram tablet taken once daily. Dosage depends on study arm.

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gln/Glu ratio in the rostral anterior cingulate cortex (rACC) from baseline to 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. Participants will undergo MR scan on Day 3 of Treatment No
Secondary Gln/Glu ratio in the rACC from baseline to 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. Participants will undergo MR scan on Day 7 of treatment No
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