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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Dysthymia
Depression Not Otherwise Specified
Borderline Personality Disorder
Drug: Lithium Carbonate
Drug: Placebo
Drug: Citalopram
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Columbia Northwest Pharmaceuticals:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Enrollment: 80
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar pill 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
Active Comparator: Lithium Drug: Lithium Carbonate
300 mg one time per day 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189812

Locations
United States, California
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Columbia Northwest Pharmaceuticals
Investigators
Principal Investigator: Arifulla Khan, MD Northwest Clinical Research Center
Principal Investigator: Vishaal Mehra, MD Aretmis Institute for Clinical Research
  More Information

No publications provided

Responsible Party: Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01189812     History of Changes
Other Study ID Numbers: LP-DP-09201
Study First Received: March 18, 2010
Results First Received: March 28, 2011
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia Northwest Pharmaceuticals:
hopelessness
alone
sad
troubled
depression

Additional relevant MeSH terms:
Borderline Personality Disorder
Depression
Depressive Disorder
Dysthymic Disorder
Personality Disorders
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Lithium Carbonate
Dexetimide
Lithium
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014