Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Depression Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305408
• Other study ID #: C10953/3073
• Secondary ID: 2010-023623-26
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2011
• Last updated: January 15, 2015
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.

• Documentation that the patient has had at least 1 previous manic or mixed episode.

• The patient has had no more than 6 mood episodes in the last year.

• The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.

• The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.

2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.

3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.

4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.

5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.

6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion Criteria:

• The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.

• The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.

• The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.

• The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
• Placebo
Matching placebo tablets, taken orally, once daily in the morning

Locations

Country	Name	City	State
Argentina	Teva Investigational Site 134	Buenos Aires
Argentina	Teva Investigational Site 136	Buenos Aires
Argentina	Teva Investigational Site 881	Buenos Aires
Argentina	Teva Investigational Site 884	Buenos Aires
Argentina	Teva Investigational Site 888	Buenos Aires
Argentina	Teva Investigational Site 236	Córdoba
Argentina	Teva Investigational Site 135	Córdoba Capital
Argentina	Teva Investigational Site 371	La Plata
Argentina	Teva Investigational Site 886	La Plata
Argentina	Teva Investigational Site 138	La Plata, Buenos Aires
Argentina	Teva Investigational Site 882	Mendoza
Argentina	Teva Investigational Site 883	Mendoza
Argentina	Teva Investigational Site 885	Mendoza
Argentina	Teva Investigational Site 887	Mendoza
Argentina	Teva Investigational Site 238	Rosario
Brazil	Teva Investigational Site 623	Belo Horizonte
Brazil	Teva Investigational Site 626	Curitiba-Parana
Brazil	Teva Investigational Site 621	Distrito de Rubiao Junior
Brazil	Teva Investigational Site 627	Itapira -Sao Paulo
Brazil	Teva Investigational Site 624	Rio de Janeiro
Brazil	Teva Investigational Site 622	Salvador
Brazil	Teva Investigational Site 628	Sao Paolo
Bulgaria	Teva Investigational Site 248	Bourgas
Bulgaria	Teva Investigational Site 146	Kardzhali
Bulgaria	Teva Investigational Site 148	Kazanlak
Bulgaria	Teva Investigational Site 853	Pazardjik
Bulgaria	Teva Investigational Site 852	Pleven
Bulgaria	Teva Investigational Site 145	Plovdiv
Bulgaria	Teva Investigational Site 370	Ruse
Bulgaria	Teva Investigational Site 147	Sofia
Bulgaria	Teva Investigational Site 149	Sofia
Bulgaria	Teva Investigational Site 244	Sofia
Bulgaria	Teva Investigational Site 247	Sofia
Bulgaria	Teva Investigational Site 854	Sofia
Bulgaria	Teva Investigational Site 855	Sofia
Bulgaria	Teva Investigational Site 245	Varna
Bulgaria	Teva Investigational Site 851	Varna
Bulgaria	Teva Investigational Site 856	Varna
Croatia	Teva Investigational Site 635	Rijeka
Croatia	Teva Investigational Site 631	Split
Croatia	Teva Investigational Site 632	Zagreb
Croatia	Teva Investigational Site 633	Zagreb
Croatia	Teva Investigational Site 634	Zagreb
Finland	Teva Investigational Site 716	Helsinki
Finland	Teva Investigational Site 717	Helsinki
Finland	Teva Investigational Site 719	Kangasala
Finland	Teva Investigational Site 718	Turku
Germany	Teva Investigational Site 655	Achim
Germany	Teva Investigational Site 656	Berlin
Germany	Teva Investigational Site 653	Cologne
Germany	Teva Investigational Site 651	Dresden
Germany	Teva Investigational Site 654	Freiburg
Germany	Teva Investigational Site 652	Mittweida
Hungary	Teva Investigational Site 661	Budapest
Hungary	Teva Investigational Site 662	Budapest
Hungary	Teva Investigational Site 664	Budapest
Hungary	Teva Investigational Site 665	Gyor
Hungary	Teva Investigational Site 666	Nagykallo
Italy	Teva Investigational Site 688	Catania
Italy	Teva Investigational Site 689	Firenze
Italy	Teva Investigational Site 686	Genova
Italy	Teva Investigational Site 691	Lido di Camaiore(LU)
Italy	Teva Investigational Site 690	Naples
Italy	Teva Investigational Site 687	Pisa
Italy	Teva Investigational Site 693	Pisa
Italy	Teva Investigational Site 692	Roma
Poland	Teva Investigational Site 259	Bialystok
Poland	Teva Investigational Site 257	Gdansk
Poland	Teva Investigational Site 258	Gdynia
Poland	Teva Investigational Site 155	Krakow
Poland	Teva Investigational Site 255	Skorzewo
Poland	Teva Investigational Site 861	Szczecin
Poland	Teva Investigational Site 157	Tuszyn
Serbia	Teva Investigational Site 177	Belgrade
Serbia	Teva Investigational Site 831	Belgrade
Serbia	Teva Investigational Site 832	Belgrade
Serbia	Teva Investigational Site 835	Belgrade
Serbia	Teva Investigational Site 176	Kragujevac
Serbia	Teva Investigational Site 837	Nis
Serbia	Teva Investigational Site 834	Novi Knezevac
Slovakia	Teva Investigational Site 700	Bojnice
Slovakia	Teva Investigational Site 699	Bratislava
Slovakia	Teva Investigational Site 697	Rimavska Sobota
Slovakia	Teva Investigational Site 696	Roznava
Slovakia	Teva Investigational Site 698	Trencin
South Africa	Teva Investigational Site 707	Cape Town
South Africa	Teva Investigational Site 709	Cape Town
South Africa	Teva Investigational Site 712	Cape Town
South Africa	Teva Investigational Site 708	Centurion
South Africa	Teva Investigational Site 710	Johannesburg
South Africa	Teva Investigational Site 711	Paarl
South Africa	Teva Investigational Site 706	Pretoria
Ukraine	Teva Investigational Site 181	Dnipropetrovsk
Ukraine	Teva Investigational Site 872	Donetsk
Ukraine	Teva Investigational Site 282	Kharkiv
Ukraine	Teva Investigational Site 281	Kiev
Ukraine	Teva Investigational Site 180	Lugansk
Ukraine	Teva Investigational Site 873	Lviv
Ukraine	Teva Investigational Site 875	Odessa
Ukraine	Teva Investigational Site 183	Poltava
Ukraine	Teva Investigational Site 871	s. Oleksandrivka
Ukraine	Teva Investigational Site 182	Vinnytsya
United States	Teva Investigational Site 406	Allentown	Pennsylvania
United States	Teva Investigational Site 116	Atlanta	Georgia
United States	Teva Investigational Site 205	Atlanta	Georgia
United States	Teva Investigational Site 225	Birmingham	Alabama
United States	Teva Investigational Site 207	Brooklyn	New York
United States	Teva Investigational Site 610	Cincinnati	Ohio
United States	Teva Investigational Site 403	Desoto	Texas
United States	Teva Investigational Site 612	Friendswood	Texas
United States	Teva Investigational Site 611	Indianapolis	Indiana
United States	Teva Investigational Site 606	Jacksonville Beach	Florida
United States	Teva Investigational Site 613	Kirkland	Washington
United States	Teva Investigational Site 600	Lafayette	Indiana
United States	Teva Investigational Site 127	Lauderhill	Florida
United States	Teva Investigational Site 202	New York	New York
United States	Teva Investigational Site 401	Oklahoma City	Oklahoma
United States	Teva Investigational Site 609	Oklahoma City	Oklahoma
United States	Teva Investigational Site 616	Oklahoma City	Oklahoma
United States	Teva Investigational Site 195	Park Ridge	Illinois
United States	Teva Investigational Site 408	Salt Lake City	Utah
United States	Teva Investigational Site 295	Sherman Oaks	California
United States	Teva Investigational Site 605	Spokane	Washington
United States	Teva Investigational Site 110	Staten Island	New York
United States	Teva Investigational Site 411	Staten Island	New York
United States	Teva Investigational Site 608	Tampa	Florida
United States	Teva Investigational Site 122	Temecula	California
United States	Teva Investigational Site 615	Toledo	Ohio
United States	Teva Investigational Site 603	Watertown	Massachusetts
United States	Teva Investigational Site 614	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Croatia,  Finland,  Germany,  Hungary,  Italy,  Poland,  Serbia,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)	The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.; Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.	Day 0 (baseline), Week 8	No
Secondary	Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score	A responder is a participant with a =50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.; Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	No
Secondary	Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score	A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.; The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.; Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	No
Secondary	Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)	The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.; Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	No
Secondary	Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)	The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	No
Secondary	Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression	The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.	Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	No
Secondary	Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale	The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.	Day 0 (baseline), Weeks 4, 8, and last postbaseline observation	No
Secondary	Participants With Treatment-Emergent Adverse Events (TEAE)	AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.; Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.	Day 1 to Week 9	Yes
Secondary	Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score	The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of =12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.	Day 0 (baseline), last postbaseline observation	Yes
Secondary	Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score	HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.	Day 0 (baseline), last postbaseline observation	Yes
Secondary	Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score	The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.	Day 0 (baseline), last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes
Secondary	Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question	The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.; The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.	Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation	Yes