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

Primary Purpose

Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Citalopram
Sponsored by
Columbia Northwest Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring hopelessness, alone, sad, troubled, depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artemis Institute for Clinical Research
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sugar pill

Lithium

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
March 18, 2010
Last Updated
August 22, 2011
Sponsor
Columbia Northwest Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01189812
Brief Title
Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia Northwest Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified, Borderline Personality Disorder
Keywords
hopelessness, alone, sad, troubled, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Title
Lithium
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
300 mg one time per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Take one time daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
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)
Primary Outcome Measure Information:
Title
Sheehan-Suicidality Tracking Scale (S-STS)
Description
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 Outcome Measure Information:
Title
Beck Hopelessness Scale (BHS)
Description
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
Title
Beck Scale for Suicide Ideation (BSS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Organizational Affiliation
Northwest Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vishaal Mehra, MD
Organizational Affiliation
Aretmis Institute for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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