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

Phase 2

Completed

• Conditions: Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Borderline Personality Disorder
• Interventions: Drug: Placebo; Drug: Lithium Carbonate; Drug: Citalopram

• Registration Number: NCT01189812
• Lead Sponsor: Columbia Northwest Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-03-28
• Results First Submitted QC: 2011-05-06
• Results First Posted: 2011-06-08
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	Placebo	-
Lithium	Lithium Carbonate	-
sugar pill	Citalopram	-
Lithium	Citalopram	-

Primary Outcome Measures

Name	Time	Method
Sheehan-Suicidality Tracking Scale (S-STS)	4 weeks; from Baseline to Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Beck Hopelessness Scale (BHS)	4 weeks	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
Beck Scale for Suicide Ideation (BSS)	4 weeks	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

Trial Locations

Locations (2)

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States