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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

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.

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Detailed Description

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Conditions

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Major Depressive Disorder Dysthymia Depression Not Otherwise Specified Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Take one time daily for 4 weeks

Citalopram

Intervention Type DRUG

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)

Lithium

Group Type ACTIVE_COMPARATOR

Lithium Carbonate

Intervention Type DRUG

300 mg one time per day for 4 weeks

Citalopram

Intervention Type DRUG

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)

Interventions

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Lithium Carbonate

300 mg one time per day for 4 weeks

Intervention Type DRUG

Placebo

Take one time daily for 4 weeks

Intervention Type DRUG

Citalopram

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)

Intervention Type DRUG

Other Intervention Names

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Celexa

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No