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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189812
• Other study ID #: LP-DP-09201
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2010
• Last updated: August 22, 2011
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: August 2011
• Source: Columbia Northwest Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Depression
• Depression Not Otherwise Specified
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymia
• Major Depressive Disorder
• Mood Disorders
• Personality Disorders

Intervention

Drug:
• Lithium Carbonate
300 mg one time per day for 4 weeks
• Placebo
Take one time daily for 4 weeks
• 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)

Locations

Country	Name	City	State
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Artemis Institute for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Columbia Northwest Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No