Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression

NCT00001483 | Completed Phase 2

• 2 other identifiers: 95012995-M-0129
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales;

1. 1.Inventory for Depressive Symptoms - Clinicians form (IDS-C)
2. 2.Clinical Global Impression scale(CGI-BP)
3. 3.Life Charting Methodology (LCM)

Conditions

Bipolar Disorder; Depressive Disorder

Keywords

Manic-Depressive Disorder; Antidepressants; Re-Randomization; Continuation; Ratings; Bipolar Illness; Depression; Bupropion; Sertraline

Interventions

buproprion (Wellbutrin) DRUG

sertraline (Zoloft) DRUG

venlafaxine (Effexor) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Subjects fulfill DSM-IV criteria for Bipolar I disorder (BPI), Bipolar II disorder (BPII), Bipolar disorder not otherwise specified (BPNOS), or schizoaffective disorder bipolar type. Subjects must be competent to comprehend the purpose of the study and provide informed consent. Subjects must undergo complete psychiatric diagnostic interview (SCID--DSM-IV), medical, neurological, and Laboratory examinations (including EKG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis B, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse). At least 18 years old. Subjects must have a depression of sufficient severity to rate greater than or equal to 16 on the Inventory of Depressive Symptomatology -Clinician (IDS-C) comparable to greater than or equal to 12 on the Hamilton Depression Rating Scale) or the clinician must decide that there is a need to treat with an antidepressant. In addition, patients must be on at least one mood stabilizer. Subjects should have no general medical illness that is causing the mood disorder. Subjects should not have liver, renal, hematological, or neurological disease. Women participants of childbearing potential must be nongravid, nonnursing, and using an acceptable method of birth control. Patients must not have alcohol or substance use or dependence of sufficient magnitude to require independent, concurrent treatment intervention (excluding self-help groups), i.e., hospitalization, day treatment programs, or counselor visits. No patients taking concomitant medications that would contraindicate the medications under study, such as chemotherapy. No history of bulimia or seizure disorder.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Davidson J. Seizures and bupropion: a review. J Clin Psychiatry. 1989 Jul;50(7):256-61.

  PMID: 2500425 BACKGROUND

• Sachs GS, Lafer B, Stoll AL, Banov M, Thibault AB, Tohen M, Rosenbaum JF. A double-blind trial of bupropion versus desipramine for bipolar depression. J Clin Psychiatry. 1994 Sep;55(9):391-3.

  PMID: 7929019 BACKGROUND

• Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.

  PMID: 8279933 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder; Depression

Interventions

Bupropion; Sertraline; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 1, 1995
• Study Completion: May 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-05

Locations

US (1)