Trial · NCT00667745
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
NCT00667745, Phase 4, Completed, National Institute of Mental Health (NIMH); results first posted 2013-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder. Trials, record NCT00667745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
- NCT number
- NCT00667745
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 283 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Bipolar Disorder
- Interventions
- Lithium Carbonate, Optimized Treatment (OPT)
- First posted
- 2008-04-28
- Last updated
- 2018-02-13
- Results first posted
- 2013-06-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score | Relevant time points: baseline and week 24 | Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant's depression, mania, and overall illness. Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients. |
| Primary | Number of Necessary Medication Adjustments | Measured over 6 months | Metric Definition (Necessary Clinical Adjustments (NCA)): Medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. This was determined with the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making. Range: whole numbers Relevant time points: Weeks 2, 4, 6, 8, 12, 16, 20, and 24. |
| Secondary | Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS) | Measured over 6 months | The MADRS is a 10-item measure and has a fixed scaling of seven points (from 0 through 6), with 0 representing sypmtoms that are not present and 6 being the most severe symptoms. When completed, the sum of each individual item is taken to create an overall score. Overall scores: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression |
| Secondary | Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Measured over 6 months | The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale with 0 indicating that symptoms are absent and 8 indicating that symptoms are severe (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale, with 0 indicating that symptoms are absent and 4 indicating that symptoms are severe (Elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, and insight). Total scores can vary from 0-60, with 0 indicating that symptoms are completely absent and 60 indicating that the patient is severely manic. |
| Secondary | Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI) | Measured over 6 months | The Modified Scale for Suicide Ideation (MSSI) assesses the presence of absence of suicide ideation and the degree of severity of suicidal ideas. The time frame is from the point of interview and the previous 48 hours. It uses 13 items from the Scale for Suicidal Ideation (SSI) and 5 new items. The modifications increased both reliability and validity. The scale was also changed to range from 0 to 3, yielding a total score ranging from 0 to 54. A total score is attained by summing all of the items. A score between 0-8 indicates low suicidal ideation; 9-20 indiciates mild-moderate suicidal ideation; 21+ indicates severe suicidal ideation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score | Relevant time points: baseline and week 24 | units on a scale | MEAN | |
| PRIMARY | Number of Necessary Medication Adjustments | Measured over 6 months | Adjustments | MEAN | |
| SECONDARY | Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS) | Measured over 6 months | units on a scale | MEAN | |
| SECONDARY | Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Measured over 6 months | units on a scale | MEAN | |
| SECONDARY | Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI) | Measured over 6 months | units of scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score | OPT With Lithium | -1.22 | Standard Deviation 1.50 | units on a scale | |
| Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score | OPT Without Lithium | -1.48 | Standard Deviation 1.37 | units on a scale | |
| Number of Necessary Medication Adjustments | OPT With Lithium | 1.17 | Standard Deviation 0.96 | Adjustments | |
| Number of Necessary Medication Adjustments | OPT Without Lithium | 1.26 | Standard Deviation 1.11 | Adjustments | |
| Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS) | OPT With Lithium | 8.20 | Standard Deviation 12.29 | units on a scale | |
| Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS) | OPT Without Lithium | 8.84 | Standard Deviation 13.59 | units on a scale | |
| Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS) | OPT With Lithium | 6.35 | Standard Deviation 10.09 | units on a scale | |
| Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS) | OPT Without Lithium | 5.79 | Standard Deviation 8.45 | units on a scale | |
| Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI) | OPT With Lithium | 0.73 | Standard Deviation 4.12 | units of scale | |
| Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI) | OPT Without Lithium | 1.10 | Standard Deviation 3.77 | units of scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPT With Lithium | 141 | |
| Overall Study | STARTED | OPT Without Lithium | 142 | |
| Overall Study | COMPLETED | OPT With Lithium | 116 | |
| Overall Study | COMPLETED | OPT Without Lithium | 121 | |
| Overall Study | NOT COMPLETED | OPT With Lithium | 25 | |
| Overall Study | NOT COMPLETED | OPT Without Lithium | 21 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aches/pains | Musculoskeletal and connective tissue disorders | OPT With Lithium | 13 | 141 | 15 |
| other | Aches/pains | Musculoskeletal and connective tissue disorders | OPT Without Lithium | 8 | 142 | 9 |
| other | Diarrhea/gastrointestinal distress | Gastrointestinal disorders | OPT With Lithium | 14 | 141 | 21 |
| other | Diarrhea/gastrointestinal distress | Gastrointestinal disorders | OPT Without Lithium | 5 | 142 | 6 |
| other | Fatigue/sedation/drowsiness | General disorders | OPT With Lithium | 20 | 141 | 20 |
| other | Fatigue/sedation/drowsiness | General disorders | OPT Without Lithium | 19 | 142 | 25 |
| other | Dizziness/Headaches | General disorders | OPT With Lithium | 8 | 141 | 9 |
| other | Dizziness/Headaches | General disorders | OPT Without Lithium | 13 | 142 | 19 |
| other | Memory/Concentration/Cognitive Impairment | Psychiatric disorders | OPT With Lithium | 10 | 141 | 11 |
| other | Memory/Concentration/Cognitive Impairment | Psychiatric disorders | OPT Without Lithium | 1 | 142 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPT With Lithium | ||
| Total, all-cause mortality | OPT Without Lithium | ||
| Total, other adverse events | OPT With Lithium | 69 | 141 |
| Total, other adverse events | OPT Without Lithium | 61 | 142 |
| Total, serious adverse events | OPT With Lithium | 14 | 141 |
| Total, serious adverse events | OPT Without Lithium | 12 | 142 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01MH080001 | TREATMENT OF BIPOLAR DISORDER-278980001 | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF MENTAL HEALTH | 1998 to 2003 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| OPT With Lithium vs OPT Without Lithium: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00667745
GET https://conductscience.org/api/trials/v1/NCT00667745/events?page=2