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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Columbia Northwest Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01189812

First received: March 18, 2010

Last updated: August 22, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2010

Last Updated Date

August 22, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sheehan-Suicidality Tracking Scale (S-STS) [ Time Frame: 4 weeks; from Baseline to Week 4 ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Sheehan-Suicidality Tracking Scale (S-STS) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

The S-STS is an 8 item scale that can be adminiistered either by a clinician or patient through self report. It is a prospective rating scale that tracks both treatment-emergent suicidal ideations and behaviors. Data can be analyzed as individual item scores, suicidal ideation subscale score, suicidal behavior subscale score and total score.

Comparison between the citalopram with lithium and the citalopram with placebo treatment groups will be made from baseline to week 4

Change History

Complete list of historical versions of study NCT01189812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Beck Hopelessness Scale (BHS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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

Original Secondary Outcome Measures ^ICMJE

Beck Hopelessness Scale (BHS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 indivituals 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) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Major Depressive Disorder
Dysthymia
Depression Not Otherwise Specified
Borderline Personality Disorder

Intervention ^ICMJE

Drug: Lithium Carbonate
300 mg one time per day for 4 weeks
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 Name: Celexa

Study Arm (s)

Placebo Comparator: sugar pill
Interventions:
- Drug: Placebo
- Drug: Citalopram
Active Comparator: Lithium
Interventions:
- Drug: Lithium Carbonate
- Drug: Citalopram

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01189812

Other Study ID Numbers ^ICMJE

LP-DP-09201

Has Data Monitoring Committee

Responsible Party

Columbia Northwest Pharmaceuticals

Study Sponsor ^ICMJE

Columbia Northwest Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Arifulla Khan, MD	Northwest Clinical Research Center
Principal Investigator:	Vishaal Mehra, MD	Aretmis Institute for Clinical Research

Information Provided By

Columbia Northwest Pharmaceuticals

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top