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

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

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Borderline Personality Disorder; Dysthymia; Depression Not Otherwise Specified
• Intervention / Treatment: Drug: Placebo; Drug: Citalopram; Drug: Lithium Carbonate

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill	Drug: Placebo; Take one time daily for 4 weeks; 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); Other Names: Celexa
Active Comparator: Lithium	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); Other Names: Celexa; Drug: Lithium Carbonate; 300 mg one time per day for 4 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia Northwest Pharmaceuticals
• Investigators: Principal Investigator: Arifulla Khan, MD, Northwest Clinical Research Center; Principal Investigator: Vishaal Mehra, MD, Aretmis Institute for Clinical Research

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: August 26, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2011
• Last Update Submitted That Met QC Criteria: August 22, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: depression; hopelessness; alone; sad; troubled
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Personality Disorders; Depression; Depressive Disorder; Disease; Mood Disorders; Depressive Disorder, Major; Borderline Personality Disorder; Dysthymic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antimanic Agents; Citalopram; Lithium Carbonate
• Other Study ID Numbers: LP-DP-09201