Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

Study Overview
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Brief Summary
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The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders

Conditions
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Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified, Borderline Personality Disorder

Intervention / Treatment
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* Drug: Lithium Carbonate
* Drug: Placebo
* Drug: Citalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years of age Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder Ability to speak, read and understand the English Language and provide written informed consent Exclusion Criteria: Current, unstable and significant medical condition or illness History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure Pregnant or lactating females Abnormal clinical laboratory test results Intolerance or hypersensitivity to SSRIs or lithium History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia Certain mediations my not be used prior or during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugar pill<br> | Drug: Placebo<br>* Take one time daily for 4 weeks<br>Drug: Citalopram<br>* All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)<br>* Other names: Celexa;|
| Active Comparator: Lithium<br> | Drug: Lithium Carbonate<br>* 300 mg one time per day for 4 weeks<br>Drug: Citalopram<br>* All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)<br>* Other names: Celexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan-Suicidality Tracking Scale (S-STS) | The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4. | 4 weeks; from Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Hopelessness Scale (BHS) | The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts. Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4 | 4 weeks | 
| Beck Scale for Suicide Ideation (BSS) | The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny. Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hopelessness, alone, sad, troubled, depression