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Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562861
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : February 13, 2017
Last Update Posted : March 24, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:

Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine.

The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression.

The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Drug: citalopram + mood stabilizer Drug: placebo + mood stabilizer Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
Study Start Date : November 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Active Comparator: citalopram + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to citalopram.
Drug: citalopram + mood stabilizer
Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.
Other Name: Celexa

Placebo Comparator: placebo + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to placebo
Drug: placebo + mood stabilizer
This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.
Other Name: lithium, lamotrigine, valproate, or carbamazepine

Primary Outcome Measures :
  1. MADRS Rating Scale Change [ Time Frame: 6 weeks ]
    Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current age ≥18 years
  • DSM-IV diagnosis of BPD, type-I, or type-II
  • Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
  • Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
  • Prior to initial evaluations, each subject must provide competent, written, informed consent.

Exclusion Criteria:

  • Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
  • Previous intolerance of R,S-citalopram;
  • Diagnosis of unipolar depression
  • Diagnosis of schizoaffective disorder
  • Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
  • Abnormal thyroid function tests
  • Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
  • Current or past renal dysfunction if taking lithium
  • Current or past hepatitis or other liver disease if taking divalproex
  • Current or past hematologic disease if on carbamazepine
  • Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
  • Presence of psychosis
  • Cognitive impairment sufficient to impair ability to give informed consent.
  • Current pregnancy, or inability to utilize contraception
  • The presence of any metallic implants
  • History of claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562861

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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Tufts Medical Center
National Institute of Mental Health (NIMH)
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Principal Investigator: Nassir Ghaemi, MD, MPH Tufts University Medical

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Responsible Party: Tufts Medical Center Identifier: NCT00562861    
Other Study ID Numbers: MH78060-01A1
5R01MH078060-04 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2007    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tufts Medical Center:
Bipolar Disorder
Bipolar Depression
Clinical Trials, Phase II
Clinical Pharmacology
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Valproic Acid
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Sodium Channel Blockers
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents