Bipolar DisorderPhase 3Geri-BD SADNCT00621842

Lamotrigine for Symptoms of Geriatric Bipolar Depression

A Phase 3 study testing Lamotrigine regular tablet formulation and Lamotrigine novel formulation in people with Bipolar Disorder and Depression, Bipolar, run by University Hospitals Cleveland Medical Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Bipolar Disorder, Depression, Bipolar
What is being tested?: Lamotrigine regular tablet formulation and Lamotrigine novel formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 5 sitesUnited States
Study dates: Jan 2008to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 60 Years or older
BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
HAM-D score > 18 (GRID-HAM-D 24-item version)
Availability of an Informant is encouraged but not required for study participation

Who cannot join

Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
Contraindication to lamotrigine (Physician interview, medical assessment)
Documented history of intolerance to lamotrigine
Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns
Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)

Show all 13Show fewer

Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity
Dementia (by DSM-IV or brain degenerative diseases; Physician interview);
Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English)
Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview)
Recent history of cardiovascular, peripheral vascular events or stroke
High risk for suicide (e.g., active SI or current intent or plan)
Inpatient status

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University Hospitals Case Medical Center/ Case Western Reserve University
Cleveland, Ohio, 44106
Baylor College of Medicine/Michael E. DeBakey VAMC
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
Weill Medical College of Cornell University
White Plains, New York, 10605

Other trials in United States

About this study

Official title: Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression

This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.

Conditions: Bipolar Disorder, Depression, Bipolar
Being tested: Lamotrigine regular tablet formulation, Lamotrigine novel formulation
Keywords: Geriatric Psychiatry, Aged, lamotrigine
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lamotrigine regular tablet formulationDrug
Also called Lamictal
Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
Lamotrigine novel formulationDrug
Also called Lamictal
Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.
Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.

Study groups in NCT00621842
Study group	Role	What they receive
Open-Label Lamotrigine Treatment	Experimental	Not described Receives: Drug: Lamotrigine regular tablet formulation; Drug: Lamotrigine novel formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: 12 weeks

Secondary outcomes (11)

Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.
Measured: 12 weeks
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
Measured: 12 weeks
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: 12 weeks
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Measured: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Measured: 12 weeks
Change in Body Weight From Baseline
Measured: 12 weeks
Number of Participants Who Fell at Least Once During the Study
Measured: 12 weeks
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Measured: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
Measured: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention
Measured: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2010

First posted22 Feb 2008 (estimated)
Study startJan 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621842
Sponsor's protocol ID: L0971
Other IDs: GSK110720, IND 78,081
Acronym: Geri-BD SAD
Status last verified: Dec 2014
First submitted: 12 Feb 2008
Last updated: 30 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression
ClinicalTrials.gov ID: NCT00621842
Acronym / sponsor ID: Geri-BD SAD / L0971
Conditions: Bipolar Disorder, Depression, Bipolar
Keywords: Geriatric Psychiatry, Aged, lamotrigine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jan 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 25 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open-Label Lamotrigine Treatment	Experimental	Drug: Lamotrigine regular tablet formulation, Drug: Lamotrigine novel formulation

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 60 Years or older
BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
HAM-D score > 18 (GRID-HAM-D 24-item version)
Availability of an Informant is encouraged but not required for study participation

Key exclusion criteria (13 listed)

Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
Contraindication to lamotrigine (Physician interview, medical assessment)
Documented history of intolerance to lamotrigine
Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lamotrigine regular tablet formulationAlso: LamictalDay 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.	Drug	Open-Label Lamotrigine Treatment
Lamotrigine novel formulationAlso: LamictalParticipants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used. Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.	Drug	Open-Label Lamotrigine Treatment

Primary outcome

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: 12 weeks
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

11 secondary outcomes

Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
Time frame: 12 weeks
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
Time frame: 12 weeks
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
Time frame: 12 weeks
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
Time frame: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
Time frame: 12 weeks
Change in Body Weight From Baseline
Time frame: 12 weeks
Number of Participants Who Fell at Least Once During the Study
Time frame: 12 weeks
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
Time frame: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention
Time frame: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
Time frame: 12 weeks

Results and safety

Results posted to the registry on 25 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label Lamotrigine Treatment	57	38

Primary outcome: Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Open-label Lamotrigine Treatment n = 54
Value	-15.5 (-18.0 to -12.9)

Open-label Lamotrigine Treatment: Mean Difference (Final Values): -15.5 (95% CI -18.0 to -12.9), p <.01, t-test, 2 sided

Population analysed: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label Lamotrigine Treatment	2 of 57 (3.5%)	22 of 57 (38.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martha Sajatovic, MD principal investigator

Case Western Reserve University School of Medicine

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.