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

Columbia Northwest Pharmaceuticals80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder Dysthymia Depression Not Otherwise Specified Borderline Personality Disorder

Interventions

Lithium CarbonateDRUG

300 mg one time per day for 4 weeks

PlaceboDRUG

Take one time daily for 4 weeks

CitalopramDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Artemis Institute for Clinical Research

San Diego, California, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks; from Baseline to Week 4

Secondary Outcomes

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

Time frame: 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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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