The purpose of the study is to explore to what extent continuing the antidepressant medication citalopram (Celexa) after depression has responded to treatment, helps prevent the return of depressive symptoms in patients with recent traumatic brain injury.

Condition	Intervention	Phase
Brain Injuries Antidepressive Agents Depression Citalopram Double-Blind Method	Drug: Citalopram	Phase IV

Further Study Details: 

Primary Outcomes: -recurrance of major depression by administering the HAM-D; and CGI every 4weeks for 40weeks
Secondary Outcomes: -general cognitive funtion at baseline, 10wks and on termination of the trial; -list of Adverse Life Events at baseline, 10wks and on termination of the trial
Expected Total Enrollment:  54

While antidepressants are effective in treating major depression following TBI, there is a lack of certainty as to how long antidepressants must be continued following improvement of symptoms. Many studies published in the last decade that strongly show that antidepressants prevent relapse in patients with major depression in the absence of traumatic brain injury (TBI). However, is it unknown as to whether this is the case following TBI. The aim of this study is to determine whether being on an antidepressant for a year reduces the risk of relapse of depression.

Patients diagnosed with major depression following mild TBI will be treated for ten weeks with the antidepressant drug citalopram. Those who respond, meaning that the symptoms of depression have lessened significantly, will be randomly assigned to either continue taking the citalopram for one year or to take a placebo for one year. Every four weeks, for an additional forty weeks, patients will be assessed for relapse of depression. This study will have a double-blind design, meaning that neither patient nor clinician know whether citalopram or placebo is being administered.

The primary outcome of interest will be a comparison of the percentage of patients who have a recurrence of major depression while continued on citalopram compared with those who were switched to placebo after the acute phase. Recurrance will be defined as meeting DSM-IV criteria for major depression and a Hamilton Depression Scale (HAM-D) score of >16. Or meeting DSM-IV criteria for major depression and having a Clinical Global Impression (CGI) severity score of >=4 and a CGI illness score of >=3. The HAM-D and CGI will be administered every four weeks for fourty weeks.

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• age >18 years
• TBI within the last year (this is consistent with our clinic population)
• mild TBI as defined above
• written, informed consent
• diagnosis of Major Depressive Episode using the depression module of the structured Clinical Interview for DSM-IV Axis I disorders (SCID-IV) (70), and baseline 17-item Hamilton Depression (HAM-D) Rating Scale Score of 16 and above (prior to SSRI treatment)
• Response to citalopram 20 or 40mg/d, as defined as a reduction in baseline HAM-D of >=50%, and HAM-D score of 10 or below
• or Response to citaloram as defined as not meeting DSM-IV criteria for major depression and Clinical Global Impresion - Severity of mildly ill, borderline ill, or normal and a Clinical Global Impression - Improvement of much improved or very much improved Impression

Exclusion Criteria:

• prior TBI or other focal brain disease (e.g., stroke, tumour)
• significant acute medical illness including: drug overdose, severely disturbed liver, kidney, lung or heart function, anemia, hypothyroidism, uncontrolled diabetes, Parkinson''''s disease, Huntington''''s chorea, progressive supranuclear palsy, brain tumor, subdural hematoma, multiple sclerosis
• current alcohol or substance abuse
• a brain computed tomographic (CT) scan revealing focal lesions that could not be interpreted as consistent with TBI
• presence of premorbid psychiatric diagnosis of schizophrenia, dementia or bipolar disorder
• prior episode of major depression in two years prior to TBI, based on SCID IV interview
• prior treatment with citalopram or contraindications to receiving treatment with citalopram

Please refer to this study by ClinicalTrials.gov identifier  NCT00162916

Andrea L Phillips, HonBA      416-480-4092    andrea.phillips@sw.ca

Canada, Ontario
      Sunnybrook & Women''''s College Health Sciences Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting

Study chairs or principal investigators

Mark J Rapoport, MD, FRCPC,  Principal Investigator,  Sunnybrook & Women''''s College Health Sciences Centre, Univeristy of Toronto   

Study ID Numbers:  rapoportm-ONF2004-abi-dep-03
Last Updated:  September 12, 2005
Record first received:  September 10, 2005
ClinicalTrials.gov Identifier:  NCT00162916
Health Authority: Canada: Ethics Review Committee
ClinicalTrials.gov processed this record on 2005-09-13