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Completed

NCT Number: NCT01189812

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Borderline Personality Disorder Depression Depression Not Otherwise Specified Depressive Disorder Depressive Disorder, Major Dysthymia Dysthymic Disorder Mental Disorders Mood Disorders Personality Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Artemis Institute for Clinical Research, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium Carbonate

Drug

300 mg one time per day for 4 weeks

Placebo

Drug

Take one time daily for 4 weeks

Citalopram

Drug

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 names: Celexa

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Columbia Northwest Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 27, 2010
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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