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

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ClinicalTrials.gov Identifier: NCT01189812
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : June 8, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Columbia Northwest Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 18, 2010
First Posted Date  ICMJE August 27, 2010
Results First Submitted Date  ICMJE March 28, 2011
Results First Posted Date  ICMJE June 8, 2011
Last Update Posted Date August 24, 2011
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
Sheehan-Suicidality Tracking Scale (S-STS) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
Sheehan-Suicidality Tracking Scale (S-STS) [ Time Frame: 4 weeks ]
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
 (submitted: August 22, 2011)
  • Beck Hopelessness Scale (BHS) [ Time Frame: 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) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Beck Hopelessness Scale (BHS) [ Time Frame: 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 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 ]
    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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: August 26, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189812
Other Study ID Numbers  ICMJE LP-DP-09201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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