Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

NCT02989727 | Completed Phase 4 Results

• 1 other identifier: GSK-SCA100223
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).

Conditions

Depression; Bipolar Disorder; Bipolar Depression; Melancholia; Lamotrigine

Outcome Measures

Primary Outcomes (18)

• Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores

  Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.

  Eight weeks

• Hamilton Depression Rating Scale (HAMD-17) Change Scores

  Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.

  Eight weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Eight weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Seven weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Six weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Five weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Four weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Three weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  Two weeks

• Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)

  Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  One week

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Eight weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Seven weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Six weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Five weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Four weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Three weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  Two weeks

• Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)

  Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  One week

Study Arms (4)

Lamotrigine - melancholic depression

EXPERIMENTAL

Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.

Drug: Lamotrigine

Placebo - melancholic depression

PLACEBO COMPARATOR

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Drug: Placebos

Lamotrigine - nonmelancholic depression

EXPERIMENTAL

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.

Drug: Lamotrigine

Placebo - nonmelancholic depression

PLACEBO COMPARATOR

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Drug: Placebos

Interventions

Lamotrigine DRUG

Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.

Also known as: Lamictal

Lamotrigine - melancholic depression; Lamotrigine - nonmelancholic depression

Placebos DRUG

Placebo tablets

Also known as: Placebo

Placebo - melancholic depression; Placebo - nonmelancholic depression

Eligibility Criteria

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

You may qualify if:

• Patients must provide written and informed consent.
• Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.
• For females, be of non-childbearing potential, or of childbearing potential with a negative pregnancy test at screening and agrees to one of (a) abstinence from sex two weeks prior and five days after drug continuation/discontinuation, (b) personal or partner sterilization, (c) one method of hormonal contraception, or (d) two barrier methods of contraception.
• Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).

You may not qualify if:

• Active suicidality.
• History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.
• History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.
• Rapid cycling bipolar disorder.
• Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.
• Received treatment for an anxiety or eating disorder within the last 12 months.
• Investigational drug use within the last month.
• History of epilepsy.

Sponsors & Collaborators

• University of Saskatchewan: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Department of Psychiatry, Royal University Hospital

Saskatoon, Saskatchewan, S7N0W8, Canada

Location

Related Links

• The ClinicalTrials.gov posting for the original study (GSK-SCA100223; NCT00274677) from which data for the present study was obtained.

MeSH Terms

Conditions

Depression; Bipolar Disorder; Depressive Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

1. Short duration of trial in context of slow dosing regime 2. Inability to assess other definitions of melancholia 3. Sample of only bipolar II depression

Results Point of Contact

• Title: Dr. Evyn Peters
• Organization: Univeristy of Saskatchewan

evyn.peters@usask.ca

13062904493

Study Officials

• Rudy C Bowen, FRCPC

  University of Saskatchewan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: November 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: December 1, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)