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Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression

Double-Blind, Acute Depression Study Comparing Venlafaxine XR and Lamotrigine When Added to Mood Stabilizer in the Treatment of Bipolar Depression

NCT00188643•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions on the Hamilton Depression Rating Scale (HDRS-29) total score \>50% from baseline. We also would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and lamotrigine.

Detailed Description

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Meets DSM-IV criteria for a diagnosis of Bipolar I disorder, most recent episode depression, or bipolar II disorder, most recent episode depression using the structured clinical interview for DSM-IV Axis 1 disorders 2. Subjects must have a Hamilton depression rating scale score of \>16. 3. Patients at visit 1 must have documented trials (levels must be obtained) of their mood stabilizer for at least 2 weeks 4. Subjects must be between the ages of 18-70, male or female 5. Treatment with oral antipsychotics, anticonvulsants or benzodiazepines prior to enrolment or during the study will be permitted, but not other antidepressants.
•6\. Female patients of childbearing potential must be using a medically accepted means of contraception.
•7\. Patient is judged by the investigator to be in generally good health 8. Education level and a degree of understanding is such that the patient can communicate effectively with the investigator.
•9\. Patient must be capable of providing informed consent.

Exclusion Criteria

•1\. Treatment with antidepressant medication within one day prior to visit 1 or during the protocol.
•2\. Patients previously showing poor therapeutic response to venlafaxine XR or lamotrigine 3. Judged clinically to be at serious suicidal risk. 4. DSM-IV criteria for substance dependence (except nicotine or caffeine) within the past 30 days 5. Course of ECT (electroconvulsive therapy) in the preceding 4 weeks prior to visit 1 or during the protocol.
•6\. Patients who suffer from a major neurological or medical illness. 7. Current diagnosis of schizophrenia or other psychotic disorders as defined in the DSM-IV 8. Uncorrected hypothyroidism or hyperthyroidism 9. Female patients who are either pregnant or nursing 10. Elevated thyroid stimulating hormone (TSH).

Locations (1)

Toronto Western Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

January 1, 2002

Completion Date

January 1, 2007

Last Updated

February 9, 2011

Enrollment

Estimated participants

Conditions

Bipolar Disorder

Interventions

Venlafaxine and Lamotrigine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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